MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problems Insufficient Cooling (1130); Contamination /Decontamination Problem (2895)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).A picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, a warning on the temperature was observed on the generator screen.Also, in one of the pictures, it can be observed a reddish material inside the pebax, however, there is no evidence of physical damage on the pebax.The biosense webster, inc.Product analysis lab received the device on (b)(6) 2022.The device evaluation was completed on (b)(6) 2022.A visual inspection, temperature and impedance test of the returned device were performed following with bwi procedures.Visual analysis of the returned device revealed reddish material inside and a hole in the pebax.Temperature, impedance tests, cool pump flow, and pressure gauge tests were performed, and the device was found working correctly.No temperature issues were observed.A manufacturing record evaluation was performed for lot 30735031m and no internal action related to the complaint was found during the review.The foreign material inside of the pebax issue reported by the customer was confirmed.The evaluation determined that the cause of pebax damage failure cannot be established.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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¿ electrophysiology catheter and the biosense webster inc, (bwi) product analysis lab observed a hole in the pebax.Initially, it was reported that during the operation, there was an issue with the temperature sensor.The system stopped the ablation when the cut-off value was exceeded.A second catheter was used to complete the operation.No adverse patient consequences were reported.The foreign material inside the pebax - no external damage issue was assessed as not mdr reportable.Since there was no damage to the pebax integrity that could cause the foreign material to travel into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The high temperature cut-off exceeded (ablation stopped) issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found reddish material in the pebax, and a hole was found.This finding was assessed as mdr reportable.The awareness date for this reportable lab finding is (b)(6) 2022.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15643302
• MDR Text Key: 307194946
• Report Number: 2029046-2022-02585
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30735031M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BRAND CATHETER.