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

Catalog Number D134722IL

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially a force issue was reported.During the procedure, there was a problem with the force of the catheter.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received.A 8.5f sheath with curve viz mdc was used.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax was not physically damaged.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 11-mar-2024 there was a hole in the pebax.Reddish material inside the pebax was also observed.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax on 11-mar-2024 and have assessed this returned condition as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 04-mar-2024.The device evaluation was completed on 11-mar-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed that there was a hole in the pebax.Reddish material inside the pebax was also observed.The damage could be related to excessive force or manipulation during or after the procedure, but this cannot be conclusively determined.The root cause of the hole remains unknown.The force feature of the device was evaluated and the force values and the vector were observed within specifications.No force issues were observed.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint were identified.The force issue reported can be confirmed, as the damage in the pebax may have affected device's sensor functionality.The pebax condition, specifically with external damage, was not originally documented in the complaint, and its exact time of occurrence cannot be determined.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19008154
• MDR Text Key: 339058923
• Report Number: 2029046-2024-01067
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134722IL
• Device Lot Number: 31147170L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• 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