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

Catalog Number D133605IL

Device Problem Positioning Problem (3009)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and deflection evaluation of the returned device was performed following bwi procedures.Visual inspection was performed and the pebax component at the tip was observed broken.Deflection test was performed, and the device failed since the puller wire was found broken inside the tip.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint were identified.The deflection issue reported by the customer was confirmed.The potential cause of the broken pebax condition and the puller wire broken cannot be determined, it could be related to the handling of the device, however, this cannot be conclusively determined.The instruction for use (ifu) states: always pull the thumb knob back to straighten the catheter tip before insertion or withdrawal of the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the broken pebax identified by bwi pal.Investigation findings: fracture problem (c070603) / investigation conclusions: cause not established (d15) / component code: steering wire (g04121) as related to the customer reported deflection issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified the pebax component at the tip was observed broken.It was initially reported by the customer that during the operation, catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.The issue was considered to be non-reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 1-apr-2024, the bwi pal revealed that a visual inspection of the returned device found the pebax component at the tip was observed broken.This finding was reviewed and assessed as an mdr reportable malfunction.

• 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: 19177223
• MDR Text Key: 341303857
• Report Number: 2029046-2024-01359
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133605IL
• Device Lot Number: 31155131M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2024
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• 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