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

Catalog Number D133604IL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/31/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that during the operation, error code '85/88' was displayed.A second device was used to complete the operation.There was no adverse event reported on patient.The customer's reported force issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On (b)(6) 2024, the bwi pal revealed that a visual inspection of the returned device found a hole on the pebax with reddish-brown material inside and internal parts exposed.These findings were reviewed and determined the issue of a hole in the pebax is an mdr reportable malfunction.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a hole on pebax with reddish-brown material inside and internal parts exposed; the hole could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this could not be conclusively determined.Then the device was connected to the carto 3 system, and the device was visualized and recognized correctly; however, error hi appeared on the system due to the reddish material in the pebax.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The force issue reported by the customer was confirmed, however, the reddish material is not related to the customer complaint.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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 ref.# (b)(4).

• 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: 18773868
• MDR Text Key: 336989020
• Report Number: 2029046-2024-00619
• 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: 02/23/2024

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: D133604IL
• Device Lot Number: 31155034M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2023
• 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