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 01/05/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified two holes on the pebax.It was initially reported by the customer that during the operation, the force value could not be zeroed.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 28-feb-2024, the bwi pal revealed that a visual inspection of the returned device found two holes in the pebax and a reddish material inside the pebax.These findings were reviewed and assessed the issue of a ¿hole¿ in the pebax 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 and screening test of the returned device were performed following bwi procedures.Visual inspection was performed, and two holes were observed on pebax's surface with reddish material inside it.The magnetic and force features were tested and no errors were observed.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 batch number, and no internal actions were identified.The reddish material inside the pebax could be related to the force issue reported by the customer therefore, the customer complaint was confirmed.The root cause of the pebax damage could be related to the manipulation of the device 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 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: 18947318
• MDR Text Key: 338207463
• Report Number: 2029046-2024-00965
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 31160871M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• 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