BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 22831802 · Received August 18, 2025

    Report

    Report Number
    2124215-2025-57491
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 24, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED FARADRIVE SHEATH DID NOT FIND ANY DEFECTS OR CONFIRM AN EXISTING LEAK PATH THAT SUPPORTED THE ALLEGATION OF AIR INGRESS AS DESCRIBED IN THE COMPLAINT SUMMARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PULSE FIELD ABLATION AND LEFT ATRIAL APPENDAGE CLOSURE (WATCHMAN) PROCEDURE TO TREAT ATRIAL FIBRILLATION FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT AFTER POST MAPPING THE ABLATION WITH NON-BOSTON SCIENTIFIC DEVICE, THE CATHETER WAS REMOVED AND A FULL 20CC ASPIRATION AND FLUSH WAS PERFORMED. TO EXCHANGE TO THE TRUSTEER SHEATH FOR THE WATCHMAN PORTION OF THE PROCEDURE, THE PHYSICIAN TOOK THE BAYLIS RF PIGTAIL WIRE AND INSERTED IT INTO THE FARADRIVE SHEATH. ONCE INSERTED PAST THE HANDLE, THE PHYSICIAN ASPIRATED (FLUSH WAS TURNED OFF PRIOR TO THIS). DURING ASPIRATION, DESPITE SEVERAL ATTEMPTS WITH TWO DIFFERENT SYRINGES, THERE WAS UN-CLEARABLE AIR ISSUES. THE PHYSICIAN THEN KEPT FLUSH OFF, THREADED THE WHITE DILATOR THAT COMES WITH THE SHEATH OVER THE WIRE AND PARTIALLY INTO THE FARADRIVE SHEATH, AND THE AIR ISSUE PERSISTED. THE PHYSICIAN DECIDED TO SWITCH TO A NON-BOSTON SCIENTIFIC SHEATH DUE TO AIR MANAGEMENT CONCERNS. IN THIS PROCESS, THE PHYSICIAN LOST TRANSSEPTAL AND HAD TO RE-PERFORM THE TRANSSEPTAL PROCEDURE THROUGH THE NON-BOSTON SCIENTIFIC SHEATH. THE TROUBLESHOOTING STEPS INCLUDED TRYING MULTIPLE SYRINGES OF ASPIRATION (UPWARDS OF 40CC) TO TRY TO CLEAR THE AIR, TRIED INSERTING DILATOR IN AS WELL IN CASE THE VALVE WAS TOO DILATED TO PROPERLY CLOSE AROUND THE WIRE (ALSO HAD AIR ISSUE WITH THIS METHOD). PRESSURE BAG WAS USED FOR THE IRRIGATION OF SHEATH. AIR WAS NOTICED IN THE SYRINGE BY PHYSICIAN WHILE ASPIRATING FARADRIVE (WITH THE RF PIGTAIL WIRE THROUGH FARADRIVE). FLUSH WAS TURNED OFF DURING THIS PROCESS AND NO AIR WAS VOCALIZED BY THE PHYSICIAN TO BE SEEN IN THE PATIENT. THE GUIDEWIRE WAS FLUSHED WITH THE TIP OF THE FARAWAVE CATHETER UPON INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PULSE FIELD ABLATION AND LEFT ATRIAL APPENDAGE CLOSURE (WATCHMAN) PROCEDURE TO TREAT ATRIAL FIBRILLATION FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT AFTER POST MAPPING THE ABLATION WITH NON-BOSTON SCIENTIFIC DEVICE, THE CATHETER WAS REMOVED AND A FULL 20CC ASPIRATION AND FLUSH WAS PERFORMED. TO EXCHANGE TO THE TRUSTEER SHEATH FOR THE WATCHMAN PORTION OF THE PROCEDURE, THE PHYSICIAN TOOK THE BAYLIS RF PIGTAIL WIRE AND INSERTED IT INTO THE FARADRIVE SHEATH. ONCE INSERTED PAST THE HANDLE, THE PHYSICIAN ASPIRATED (FLUSH WAS TURNED OFF PRIOR TO THIS). DURING ASPIRATION, DESPITE SEVERAL ATTEMPTS WITH TWO DIFFERENT SYRINGES, THERE WAS UN-CLEARABLE AIR ISSUES. THE PHYSICIAN THEN KEPT FLUSH OFF, THREADED THE WHITE DILATOR THAT COMES WITH THE SHEATH OVER THE WIRE AND PARTIALLY INTO THE FARADRIVE SHEATH, AND THE AIR ISSUE PERSISTED. THE PHYSICIAN DECIDED TO SWITCH TO A NON-BOSTON SCIENTIFIC SHEATH DUE TO AIR MANAGEMENT CONCERNS. IN THIS PROCESS, THE PHYSICIAN LOST TRANSSEPTAL AND HAD TO RE-PERFORM THE TRANSSEPTAL PROCEDURE THROUGH THE NON-BOSTON SCIENTIFIC SHEATH. THE TROUBLESHOOTING STEPS INCLUDED TRYING MULTIPLE SYRINGES OF ASPIRATION (UPWARDS OF 40CC) TO TRY TO CLEAR THE AIR, TRIED INSERTING DILATOR IN AS WELL IN CASE THE VALVE WAS TOO DILATED TO PROPERLY CLOSE AROUND THE WIRE (ALSO HAD AIR ISSUE WITH THIS METHOD). PRESSURE BAG WAS USED FOR THE IRRIGATION OF SHEATH. AIR WAS NOTICED IN THE SYRINGE BY PHYSICIAN WHILE ASPIRATING FARADRIVE (WITH THE RF PIGTAIL WIRE THROUGH FARADRIVE). FLUSH WAS TURNED OFF DURING THIS PROCESS AND NO AIR WAS VOCALIZED BY THE PHYSICIAN TO BE SEEN IN THE PATIENT. THE GUIDEWIRE WAS FLUSHED WITH THE TIP OF THE FARAWAVE CATHETER UPON INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044151 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL14081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown