BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 22920911 · Received August 29, 2025

    Report

    Report Number
    2124215-2025-60849
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 1, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    UDI-DI
    00191506043131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: THE REFERENCED FARADRIVE STEERABLE SHEATH WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE DEVICE NOTED NO ABNORMALITIES. MICROSCOPIC INSPECTION OF THE HEMOSTATIC VALVE IDENTIFIED TEARS IN BOTH THE INNER AND OUTER VALVE. PRESSURE AND VACUUM TESTING WERE PERFORMED, AND THE SHEATH EXHIBITED LEAKING (BOTH AIR INGRESS AND FLUID EGRESS) THROUGH THE TEAR ON THE VALVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT SHEATH 1 (TW: (B)(4)) WAS PREPPED AS RECOMMENDED, INSERTED INTO LEFT ATRIUM WITH NO ISSUE AFTER REMOVAL OF WIRE/DILATOR IT WAS NOTED THAT THE SHEATH WAS LEAKING AND SUCKING AIR. SHETH 2 (TW: (B)(4)) WAS PREPPED AS RECOMMENDED, INSERTED TO LEFT ATRIUM AND DILATOR/WIRE WAS REMOVED WITH NO AIR ASPIRATED. WHEN FARAWAVE WAS INSERTED INTO SHEATH UNTIL JUST PAST HANDLE. STOP COCK OFF TO PATIENT AND FLUSH LINE HOOKED INTO FD. SYRINGE ATTACHED AND STOP COCK TURNED OFF TO FLUSH AND 20CC BLOOD PULLED BACK. STOP COCK TURNED OFF TO PATIENT AND SMALL BUBBLES IMMEDIATELY NOTED IN CLEAR FLUSH PORT LINE. AFTER REPEATING IT FOR 3-4 TIMES NEW SHEATH WAS ASKED BY PHYSICIAN. SHEATH 3 (TW: (B)(4)) PREPPED IN USUAL FASHION WITH NO ISSUES NOTED. INSERTED OVER THE WIRE INTO THE LEFT ATRIUM. DILATOR/WIRE REMOVED AND AIR/BLOOD ASPIRATED. NO ISSUES NOTED. FARAWAVE INSERTED INTO SHEATH UNTIL JUST PAST HANDLE. STOP COCK OFF TO PATIENT. SYRINGE ATTACHED AND STOP COCK TURNED OFF TO AIR AND 20CC BLOOD PULLED BACK. STOP COCK TURNED OFF TO PATIENT AND SMALL BUBBLES IMMEDIATELY NOTED IN CLEAR FLUSH PORT LINE. ANOTHER SYRINGE ATTACHED AND ANOTHER 20CC OF BLOOD PULLED WITH SAME RESULT. PHYSICIAN REQUESTED 1 MORE SHEATH OR HE WAS GOING TO ABORT CASE. 4TH SHEATH PERFORMED PROPERLY, AND CASE WAS COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DIFFERENT DEVICE (SAME MODEL). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED. 13AUG2025: GFE RESPONSE RECEIVED- PUMP AT 150CC/HR WAS USED HOWEVER, THE SHEATH WAS NEVER CONNECTED TO THE PUMP AS THE FAILURE WAS NOTED DURING THE FIRST ASPIRATION BEFORE FLUSH WAS CONNECTED. NO FLUID LEAK WAS NOTES AND NO AIR IN PATIENT SEEN. FARADRIVE DILATOR HAD BEEN INSIDE THE SHEATH PRIOR TO, AND/OR AT THE TIME, THE AIR WAS OBSERVED AS THE HEMOSTATIC VALVE WAS NOTED TO BE DRAWING IN AIR DURING FIRST ASPIRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT SHEATH 1 (B)(4) WAS PREPPED AS RECOMMENDED, INSERTED INTO LEFT ATRIUM WITH NO ISSUE AFTER REMOVAL OF WIRE/DILATOR IT WAS NOTED THAT THE SHEATH WAS LEAKING AND SUCKING AIR. SHETH 2 (B)(4) WAS PREPPED AS RECOMMENDED, INSERTED TO LEFT ATRIUM AND DILATOR/WIRE WAS REMOVED WITH NO AIR ASPIRATED. WHEN FARAWAVE WAS INSERTED INTO SHEATH UNTIL JUST PAST HANDLE. STOP COCK OFF TO PATIENT AND FLUSH LINE HOOKED INTO FD. SYRINGE ATTACHED AND STOP COCK TURNED OFF TO FLUSH AND 20CC BLOOD PULLED BACK. STOP COCK TURNED OFF TO PATIENT AND SMALL BUBBLES IMMEDIATELY NOTED IN CLEAR FLUSH PORT LINE. AFTER REPEATING IT FOR 3-4 TIMES NEW SHEATH WAS ASKED BY PHYSICIAN. SHEATH 3 (B)(4) PREPPED IN USUAL FASHION WITH NO ISSUES NOTED. INSERTED OVER THE WIRE INTO THE LEFT ATRIUM. DILATOR/WIRE REMOVED AND AIR/BLOOD ASPIRATED. NO ISSUES NOTED. FARAWAVE INSERTED INTO SHEATH UNTIL JUST PAST HANDLE. STOP COCK OFF TO PATIENT. SYRINGE ATTACHED AND STOP COCK TURNED OFF TO AIR AND 20CC BLOOD PULLED BACK. STOP COCK TURNED OFF TO PATIENT AND SMALL BUBBLES IMMEDIATELY NOTED IN CLEAR FLUSH PORT LINE. ANOTHER SYRINGE ATTACHED AND ANOTHER 20CC OF BLOOD PULLED WITH SAME RESULT. PHYSICIAN REQUESTED 1 MORE SHEATH OR HE WAS GOING TO ABORT CASE. 4TH SHEATH PERFORMED PROPERLY, AND CASE WAS COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DIFFERENT DEVICE (SAME MODEL). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED. IT WAS FURTHER REPORTED THAT A PUMP AT 150CC/HR WAS USED HOWEVER, THE SHEATH WAS NEVER CONNECTED TO THE PUMP AS THE FAILURE WAS NOTED DURING THE FIRST ASPIRATION BEFORE FLUSH WAS CONNECTED . NO FLUID LEAK WAS NOTES AND NO AIR IN PATIENT SEEN. FARADRIVE DILATOR HAD BEEN INSIDE THE SHEATH PRIOR TO, AND/OR AT THE TIME, THE AIR WAS OBSERVED AS THE HEMOSTATIC VALVE WAS NOTED TO BE DRAWING IN AIR DURING FIRST ASPIRATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2879208 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION CL14123 00191506043131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown