MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134804

Device Problems High Readings (2459); Low Readings (2460); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 2-jul-2021.Visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related with the handling since in the process there are control inspection points to avoid this kind of issues.Force testing was performed and observed that the catheter was displayed properly.The evaluation determined that the cause of the pebax damage failure cannot be established.However, the blood found inside the pebax area may have contributed to the high force error reported.A manufacturing record evaluation was performed for the finished device 30509887m number, and no internal action was found during the review.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: -for force issue of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.(bwi) product analysis lab observed a cut on the pebax with reddish-brown material inside and internal parts exposed.Initially, it was reported that during ablation, the force readings would go up from 6-10 and 30-35.The cable was exchanged, and the issue persisted.The catheter was exchanged, and the issue was resolved, and the case was completed without any further incident.The carto 3 system was working per specification.There was no patient consequence reported.The force high and force low issues were assessed as not mdr reportable.These issues are highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.This event is being reported because the biosense webster, inc.Product analysis lab received the device for evaluation and found on 28-jun-2021 that there was a cut on the pebax and reddish material inside of it.The cut on the pebax was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 28-jun-2021.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12223420
• MDR Text Key: 263448431
• Report Number: 2029046-2021-01180
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30509887M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1