Class 2 Device Recall PENTARAY NAV HighDensity Mapping Catheter

• Date Initiated by Firm: April 22, 2020
• Create Date: June 16, 2020
• Recall Status: Terminated on December 15, 2022
• Recall Number: Z-2371-2020
• Recall Event ID: 85559
• 510(K)Number: K120425
• Product Classification: Catheter, intracardiac mapping, high-density array - Product Code MTD
• Product: 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.
• Code Information: This field action includes all lots of the following product codes: D-1282-07, D-1282-08, D-1282-10 and D-1282-11 The other product codes listed in the 806 report for the PENTARAY NAV High-Density Mapping Catheter: D128201, D128202, D128203, D128204, D128205, D128206 are out of scope of this recall because they were not manufactured during the period that is subject to this field action (2016 or later). Product Code Product Description GTIN Number D-1282-01-S PENTARAY¿ NAV, 7FR, F, 4-4-4 10846835009576 D-1282-02-S PENTARAY¿ NAV, 7FR, F, 2-6-2 10846835009583 D-1282-03-S PENTARAY¿ NAV, 7FR, F, 1-8-1 10846835009590 D-1282-04-S PENTARAY¿ NAV, 7FR, D, 4-4-4 10846835009606 D-1282-05-S PENTARAY¿ NAV, 7FR, D, 2-6-2 10846835009613 D-1282-06-S PENTARAY¿ NAV, 7FR, D, 1-8-1 10846835009620 Note - the firm is including the above code information for products that will be distributed to new customers. No Lot Numbers.
• Recalling Firm/ Manufacturer: BIOSENSE WEBSTER; 33 TECHNOLOGY DRIVE; IRVINE CA 92618
• Manufacturer Reason for Recall: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
• FDA Determined Cause: Error in labeling
• 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
• Quantity in Commerce: 0 units (Products were not manufactured from 2016 and later)
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MTD and Original Applicant = BIOSENSE WEBSTER, INC.