MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D133603
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 11-sep-2024.The device evaluation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and magnetic sensor functionality test of the returned device were performed following j&j medtech procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.A magnetic sensor functionality was performed and the device was recognized; however, the device could not be visualized since error 105 appeared on the system due to an open circuit in the tip area.The magnetic sensor error issue reported by the customer was confirmed due to the open circuit.The potential cause of the open circuit could not be conclusively determined.The potential cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this could not be conclusively determined.The instruction for use (ifu) of the carto 3 system contain the following recommendations: the magnetic sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.The instruction for use (ifu) of the device contains the following recommendations: do not scrub or twist the distal tip electrode during cleaning.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as per the biosense webster¿s inc.Product analysis lab finding of the ¿reddish material and a hole in the surface of the pebax¿ issue.-investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected related to the customer¿s reported "sensor 105 error¿ issue.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial flutter (afl) procedure with thermocool smarttouch for which biosense webster¿s product analysis lab (pal) identified a hole in the surface of the pebax.Initially it was reported that the catheter presented with sensor 105 error.The connector was changed and the error persisted.The catheter was changed and it resolved.The procedure was not delayed due to the reported event.The procedure was successfully completed.There was no patient consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 07-oct-2024, observed reddish material and a hole in the surface of the pebax.The event was originally considered non-reportable, however, bwi became aware of a hole in the surface of the pebax on 07-oct-2024 and have assessed this returned condition as reportable.

• Brand Name: THERMOCOOL SMARTTOUCH
• Common Device Name: 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: 20563954
• Report Number: 2029046-2024-03503
• Device Sequence Number: 15450692
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: (01)10846835009019(17)260117(10)30979710M
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2026
• Device Catalogue Number: D133603
• Device Lot Number: 30979710M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown