BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE

    MDR report key: 18156549 · Received November 16, 2023

    Report

    Report Number
    2024168-2023-12808
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 26, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NTE
    PMA / PMN Number
    K141678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NAME1: FACILITY NAME AND ADDRESS CORRECTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY REVEALED NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. BASED ON THE INFORMATION PROVIDED, THE DIFFICULTY REMOVING, AND SUBSEQUENT KINK OF THE BAREWIRE TIP APPEARS TO BE DUE TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT CLEARANCE BETWEEN THE INNER DIAMETER OF THE NON-ABBOTT ATHERECTOMY DEVICE AND OUTER DIAMETER OF THE BAREWIRE BECAME REDUCED DURING USE, RESULTING IN A KINK AND CAUSING DIFFICULTY TO REMOVE. THE SEPARATION APPEARS TO BE DUE TO THE KINKED PORTION OF THE BAREWIRE INTERACTING WITH THE HEMOSTATIC VALVE DURING REMOVAL RESULTING IN SEPARATION. REPORTEDLY, THE SEPARATED PORTION WAS SIMPLY WITHDRAWN USING A HEMOSTATIC FORCEPS THROUGH THE VALVE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D4: PART/LOT # UPDATED FROM UNK BAREWIRE TO 22445-31, LOT # 1111661.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THAT SEPARATED PORTION WAS SIMPLY WITHDRAWN USING A HEMOSTATIC FORCEPS THROUGH THE VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SAPHENOUS BYPASS THROMBECTOMY PROCEDURE THE BAREWIRE 315 GUIDE WIRE WAS POSITIONED IN THE PERONEAL ARTERY AND THE EMBOSHIELD NAV6 FILTER IN THE TIBIOFIBULAR TRUNK. DURING THE FORWARD AND BACKWARD MOVEMENTS OF THE THROMBECTOMY DEVICE, WHICH WERE SEVERAL, THE DISTAL END OF THE GUIDE WAS OFTEN NOT VISIBLE. AT THE END OF THE PROCEDURE BEFORE CAPTURING THE FILTER IT WAS NOTED THAT THE MOVEMENT HAD MOVED THE GUIDE WIRE, WHICH IN TURN PRESENTED A BENDING LIKE KINK. WHEN REMOVING THE FILTER TOGETHER WITH THE GUIDE WIRE, THE DISTAL END OF THE WIRE SEPARATED AND BECAME TRAPPED IN THE HEMOSTATIC VALVE OF THE INTRODUCER SHEATH. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154055 BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR 1111661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HEMOSTATIC VALVE| ROTAREX THROMBECTOMY