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

Catalog Number	D132705
Medical Device Problem Codes	Insufficient Cooling (1130); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 9-mar-2026, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a right atrial flutter right (r-afl) ablation procedure with a thermocool smarttouch for which had an irrigation issue during use on the patient.It was reported by the customer that the thermocool smarttouch catheter stopped irrigating and when attempting to ablate the first time, an error appeared on the generator indicating "high heat," (code unknown).It was then discovered that the irrigation tubing had become disconnected.Attempted flushing was unsuccessful, irrigation ports were occluded.The catheter was exchanged for a thermocool smarttouch sf (stsf) catheter to resolve and continue the case successfully.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent a right atrial flutter right (r-afl) ablation procedure with a thermocool smarttouch for which had an irrigation issue during use on the patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection, irrigation, temperature and impedance test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to the generator and an ablation cycle was performed; the device failed the test due to a high temperature error.An irrigation test was performed, and the device failed the test due to being occluded with dry reddish material inside the dome.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The high temperature and irrigation issue reported by the customer were confirmed.The root cause of the irrigation and temperature issue was traced to a user error since according to the reported event it was discovered that the irrigation tubing had become disconnected during the procedure.The instructions for use (ifu) contain the following information: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.As part of johnson & johnson medtech'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 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24586205
• Report Number: 2029046-2026-00814
• Device Sequence Number: 18486192
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(17)290108(10)31829973M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: D132705
• Device Lot Number: 31829973M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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: UNK_SMART TOUCH UNIDIRECTIONAL SF.; UNK_SMARTABLATE GENERATOR.; UNK_SMARTABLATE PUMP TUBING.
• Patient Sex: Unknown