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PENTARAY NAV recallZ-2371-2020 · Biosense Webster · initiated Apr 22, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biosense Webster or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Error in labeling

What the company is doing

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

Recall details

Recall number
Z-2371-2020
Status
Terminated
Initiated by the company
Apr 22, 2020
Recalling firm
Biosense Webster
Quantity
0 units (Products were not manufactured from 2016 and later)
Product code
MTD
FDA submissions
K120425
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.

Product description

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 (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 85559).

Sources and updates

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