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

Catalog Number	D134702
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on (b)(6) 2025.Following j&j medtech procedures, a visual inspection and magnetic sensor functionality test of the returned device were performed.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.The device was connected to the carto 3 system and it was recognized and visualized correctly.No magnetic sensor error or failures were observed.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.The magnetic sensor error reported by the customer could not be replicated, however, the reddish material on the pebax could be related to the magnetic issue.Therefore, the complaint was confirmed.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 instructions for use state: do not scrub or twist the tip electrode as damage to the tip electrode bond may occur and loosen the tip electrode, or damage may also occur to the contact force sensor and affect measurement accuracy.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool smarttouch sf catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed.They got a magnetic sensor error # 105 when the thermocool smarttouch sf catheter was connected to the patient interface unit (piu) on the carto 3 system.Changing out the catheter cable did not resolve the error.Changing out the catheter resolved the error and the procedure was continued and subsequently completed.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2025, observed reddish brown material inside and a hole on the pebax with internal parts exposed.The event was originally considered non-reportable, however, bwi became aware of a hole on the pebax with internal parts exposed on (b)(6) 2025 and have assessed this returned condition as reportable.

• Brand Name: THERMOCOOL SMARTTOUCH SF
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23088842
• Report Number: 2029046-2025-03209
• Device Sequence Number: 9693368
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: (01)10846835009781(17)280306(10)31549210L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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 Catalogue Number: D134702
• Device Lot Number: 31549210L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; UNK CATHETER CABLE.; UNK_OCTARAY NAV.
• Patient Sex: Unknown