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

Catalog Number	D134701
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation afib ¿ persistent ablation procedure with a thermocool smarttouch sf (stsf) and the catheter end was pulled out leaving its wires exposed.The report indicated that the patient was prepped and draped in normal fashion.The stsf ablation catheter was advanced into the patient as normal, and a fast anatomical mapping (fam) of the right atrium was created.The transeptal puncture was performed and the stsf was advanced into the left atrium where it was zeroed appropriately.Upon ablation, there were extremely high force readings.Upon re zeroing, the catheter functioned as normal while delivering more ablations.Then, during one ablation, the catheter disappeared off the screen and then appeared in a different location.It did resolve after a few seconds and returned to its accurate position.Force sensor error then appeared on carto.After unplugging and re-plugging the error persisted.Then, as the physician disconnected the catheter from the cable, the catheter end was pulled out leaving its wires exposed and the cable still connected.After disconnecting the catheter and replacing it with a new one, the error was resolved on carto, and there were no further issues.The case continued as normal.The surgery was delayed by ten minutes due to the reported event.The procedure was successfully completed.No adverse patient consequence was reported.
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.The 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 reference number: (b)(4).
Additional Manufacturer Narrative
During an internal review on 26-feb-2026, it was noted that the wrong h 6.Medical device problem code of material protrusion / extrusion (a0411) was submitted on the initial mw report.The correct code is detachment of device or device component (a0501) which is not mdr reportable.Therefore, h6.Medical device problem code has been updated on this report, and this event is no longer considered mdr reportable.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: 24320399
• Report Number: 2029046-2026-00451
• Device Sequence Number: 15935432
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: (01)10846835009774(17)280121(10)31542277L
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 03/25/2026

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: D134701
• Device Lot Number: 31542277L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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: UNK CABLE; UNK_CARTO 3
• Patient Sex: Unknown