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

Catalog Number D134722IL

Device Problems Erratic or Intermittent Display (1182); Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/08/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation - paroxysmal ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a hole in the pebax was identified.During the procedure, the icon was waggling on the carto system screen.There was a problem with the force of the catheter.A second device was used to complete the operation.There was no adverse event reported on patient.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, magnetic sensor functionality test, and screening test of the returned device were performed following bwi procedures.Visual inspection was performed; a hole and reddish material were observed in the pebax component.The magnetic and force features were tested on the carto and no jumpin icon was observed; however, high force values were observed.This issue could be related to the reddish material inside the pebax component.A manufacturing record evaluation was performed for the finished device [31085326l] number, and no internal actions related to the reported complaint condition were identified.The reported issues by the customer were confirmed.The root cause of the hole on the pebax could be related to the manipulation during the procedure; however, this cannot be conclusively determined.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 18370056
• MDR Text Key: 331228865
• Report Number: 2029046-2023-03047
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 31085326L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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
• Treatment: CARTO 3 SYSTEM