MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D134703
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection, magnetic sensor functionality and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed a hole on the pebax.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no errors appeared during the test.An electrical test was performed, and current leakage has been detected.The device was dissected and reddish material was observed on the printed circuit board (pcb) due to the hole on the pebax.The root cause of the damage on the pebax and the reddish material on the pcb could not be conclusively determined, but it was concluded that it occurred outside the bwi manufacturing facilities and could be related to the failure described by the customer.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Note: the date of event was not provided.As such, field b3.Date of event has been populated with (b)(6) 2023.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a cadiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that during the ablation process, the error of current leakage came for 3 times.Then we decided to change the ablation cable but the error remained.We changed the ablation catheter which was thermocool® smart touch® sf uni-directional navigation catheter and then the error has been gone.Therefore the catheter was defect.The "current leakage error" was displayed because of signal noise and also after that signal loss issue because this error came 3 to 4 times.This signal interference showed up on all ecg (bs+ ic) channels.It was observed on both devices (carto & recording system as well).Their monitoring systems were working well, the only issue was on recording system.The affected catheter was in the patient¿s body at the time of incident but there were no circumstances on the patient.The catheter was changed so fast and then everything worked well again.The customer¿s reported issues are not considered to be mdr reportable since the risk to the patient is low.On 6-jun-2023, the bwi pal revealed that a visual inspection of the returned device found a hole on the pebax.The issue of a hole in the pebax has been assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17223652
• Report Number: 2029046-2023-01421
• Device Sequence Number: 7076104
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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 Expiration Date: 05/31/2025
• Device Model Number: D134703
• Device Catalogue Number: D134703
• Device Lot Number: 30787939L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: THMCL SMTCH SF UNID, TC, J; UNKNOWN CATHETER CABLE
• Patient Sex: Unknown