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

Catalog Number	D134702
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and force test of the returned device were performed following j&j medtech procedures.Visual analysis revealed that the pebax was broken.A force test was performed, and the device was recognized correctly; however, error 105 and 106 were displayed on screen.Due to this condition, the handle of the device was dissected, and resistance of the sensor pads on the printed circuit board (pcb) was measured and an open circuit on the tip was identified.In addition, further investigation of the peek housing section revealed that there was insufficient adhesive on the wires.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The force issue reported by the customer was confirmed.The hole in the pebax is not related to the issue reported by the customer.The potential cause of the open circuit could not be determined.The root cause of the adhesive condition was traced to the manufacturing process.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 (ifu) contain the following information: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Internal corrective actions are being performed to address process opportunities related to adhesive issues.Explanation of codes: -investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: adhesive (g0405201) were selected as related to adhesive condition noted during the investigation.-investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / sleeve (g04115) were selected as related to broken pebax that was observed during the investigation.-investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to open circuit on the tip of the device that was identified during the investigation.-investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: adhesive (g0405201) were selected as related to the insufficient adhesive on the wires that were observed during the investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch sf and an issue with wrong force on catheter, not able to zero properly was observed.It showed "high force" when not in contact with tissue.There was no adverse event reported on the patient.This event was originally assessed as not mdr reportable.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and force test of the returned device were performed.Visual analysis revealed that the pebax was broken.This finding is mdr 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: 24090692
• Report Number: 2029046-2026-00204
• Device Sequence Number: 21397264
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: (01)10846835009781(17)280903(10)31742665L
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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: 31742665L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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
• Patient Sex: Unknown