MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Temperature Problem (3022)

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

Event Date 09/19/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a cut/hole on the pebax.It was initially reported by the customer that during the operation, there is no temperature displayed on the carto or generator.A second device was used to complete the operation.There was no adverse event reported on patient.The customer¿s reported issue of no temperature display is not considered to be mdr reportable since the most likely consequence is an intraprocedural delay and the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On (b)(6) 2022, the bwi pal revealed that a visual inspection of the returned device found a cut and a reddish material in the pebax.This finding was reviewed and assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, temperature and impedance tests of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a cut and a reddish material in the pebax.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.Then a temperature and impedance tests were performed, and the device was found working correctly.No temperature or impedance issues were observed.The issue reported by the customer could not be replicated during the product investigation; the blood inside the pebax could be related to the issue reported by the customer however this cannot be conclusively determined.The instructions for use contain the following recommendations: if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.A manufacturing record evaluation was performed, and no non-conformance was found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 15849813
• MDR Text Key: 307915768
• Report Number: 2029046-2022-02915
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30801176M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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
• Treatment: CARTO 3 SYSTEM.; THMCL SMARTTOUCH,TC,D,C3,OBL.; UNKNOWN GENERATOR.