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

Catalog Number	D134701
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch sf catheter and there was coagulation in front of the third electrode.The medical team was unable to remove a single coagulation thread from the device.The system did not display any error messages.The doctor discovered the coagulation when he wanted to reinsert the catheter, but he did not use the catheter any further since he was unable to remove the coagulate that was already on it.The average catheter force did not exceed 25 grams or 40 grams for any extended periods of time.The irrigation rate was within the prescribed parameters (power up to 30 w, high flow rate of 8 ml/min; 31 w or greater, high flow rate of 15 ml/min; varipulse catheter high flow rate 30ml/min; stsf de: pf ablation flow rate of 4 ml/min).Heparinized normal saline had been used at he irrigation fluid.The following carto visitag parameters were used: respiration setting, stability range, stability time, force over time, & tag size.3mm, 3sec, 25% & 3.No further details were provided regarding completion of the procedure.No patient consequences were reported.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and microscopy examination of the returned device were performed following j&j procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.The damage on the pebax's surface could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device number lot 31776025l and no internal action related to the complaint was found during the review.The thrombus/clot issue reported by the customer could be related to the reddish material identified during the investigation; therefore the complaint was confirmed.The potential cause of the issue is due to an unintended use error caused or contributed to the event.The instruction for use states: when cleaning the tip electrode, be careful not to twist the tip electrode with respect to the catheter shaft; twisting may damage the tip electrode bond and loosen the tip electrode, or may damage the contact force sensor.In addition, in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.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 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: 24916776
• Report Number: 2029046-2026-01267
• Device Sequence Number: 9823779
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: (01)10846835009774(17)281013(10)31776025L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 31776025L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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