Terminated

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

FDA Recall Z-2371-2020 · Posted None

Recalling FirmBIOSENSE WEBSTER

Recall StatusTerminated

Product CodeMTD

Date Initiated2020-04-22

Date Terminated2022-12-15

Product Quantity0 units (Products were not manufactured from 2016 and later)

Reason for Recall

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

Firm Action

On 4/22/2020 the firm issued an "URGENT Medical Device Correction" letter via UPS/certified mail, informing them that as a result of 3 complaints in 2019 in which a catheter became entrapped in the cardiac valvular apparatus while the user was attempting to create an electroanatomic map, leading to the need for surgical intervention for removal, the firm is performing a correction to the products. The Notification Letter informs customers: Following are learnings that users of this product should be aware of to avoid or address entrapment: " Repeated rotation of the catheter near the valvular apparatus may result in the entanglement of the product spines and further rotation could result in entrapment, leading to the need for surgical intervention. " A common use scenario for repeated rotation leading to entanglement may occur during mapping of the right ventricle and accessing of the right ventricular outflow tract using clockwise rotation. Caution should be exercised with manipulation to avoid spine entanglement with valvular structures. " Entanglement of the catheter can be identified by resistance felt by the user and a lack of movement of the spines during manipulation, which can be seen via the CARTO 3 System or by fluoroscopy. The device may appear in a broom-like configuration with entangled spines pointing in a single direction. With opposite manipulation (e.g. counterclockwise rotation for initial clockwise rotation), it may be possible to free the entangled device for safe removal. " Do not use excessive force to remove the device when entangled or entrapped as it may lead to damage to the cardiac structures or to the device. The firm is instructing customers: 1. Please maintain awareness of this letter and pass it on to anyone in your facility that needs to be informed. 2. Please complete, sign, and return the Business Reply Form. We have communicated this information to the applicable regulatory authorities. Method of Notification/M

Root Cause

Error in labeling

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI IL, VA,, NE, OK, NJ, CT, KS, HI, CO, ND, RI, ID, MS, VT, DC and WV. The countries of (EMEA, APAC, LATAM, US, Canada) including: NZ,BE,DE,PL,SI,TR,HU,CO,KR,CL,PE,AU,BR,CA,CN,HK,ID,JP,MY,MX,PH,RU,SG,TW,TH,IL,AT,FR,GR,DE,IE,IT,PL,NL,PT,ES,SE,DK,NO,FI,CH,GB,RO,SI,HR,CZ,TR,ZA,AE,BR,ID,BE,PA,CR,CL,NZ,HK,RU,GR,NL,EG,QA,LU,NL,CH,AT,IE,CY. See Attachments 2 & 3 for a distribution list including all domestic and foreign consignees of the device, addresses and phone numbers and the dates and number of devices distributed to each such consignee.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120425PENTARAY NAV HIGH-DENSITY MAPPING CATHETERBiosense Webster, Inc. · 2012-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.