BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2831618 · Received November 14, 2012

    Report

    Report Number
    3004939290-2012-00413
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE WAS ENGAGED TO THE HANDLE AND WITH THE PROCEDURAL SHEATH PULLED BACK AGAINST THE SHUTTLE. THE SEALANT WAS EXPOSED 2 MM FROM THE BALLOON. THE SEALANT GRIP TIP WAS ADHERED TO THE POLYIMIDE SHAFT. THE ADVANCER TUBE WAS PUSHED PAST THE PROXIMAL TAMP LOCK, WITH THE DISTAL TIP COMPRESSING AGAINST THE SEALANT. A SMALL PIECE OF SEALANT WAS ADHERED TO THE DISTAL END OF THE SHUTTLE CARTRIDGE. THE SHUTTLE CARTRIDGE WAS RETRACTED AND SLIGHT RESISTANCE WAS FELT. THE CATHETER SHAFT, THE ADVANCER TUBE AND THE SHUTTLE CARTRIDGE WERE INSPECTED FOR KINKS OR ANY PRESENCE OF ADHESIVE. NO ANOMALIES WERE OBSERVED. THE ROOT CAUSE OF THE JAM COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1220203) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. SEE MEDWATCH REPORT 3004939290-2012-00414 FOR THE SECOND DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI CLINICAL SPECIALIST THAT A PATIENT UNDERWENT A DIAGNOSTIC PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE RIGHT AND LEFT (BILATERAL STICK) COMMON FEMORAL ARTERY (CFA) VIA A 5F SHEATH (UNKNOWN MODEL). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE GREATER THAN 5MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS INSERTED INTO THE RIGHT CFA AND THE PHYSICIAN WAS ABLE TO SHUTTLE DOWN BUT WAS NOT ABLE TO UNSHEATHE THE DEVICE. THE DEVICE HAD JAMMED. THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED FROM THE RIGHT CFA. MANUAL PRESSURE WAS HELD AT THE ACCESS SITE FOR APPROXIMATELY 10-15 MINUTES IN WHICH TIME HEMOSTASIS WAS ACHIEVED. A SECOND MYNXGRIP VASCULAR CLOSURE DEVICE 5F WAS PREPPED AND DEPLOYED IN THE LEFT CFA. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SHUTTLE DOWN THE SECOND DEVICE BUT WAS NOT ABLE TO UNSHEATHE THE DEVICE. THE SECOND DEVICE ALSO JAMMED. THE BALLOON FROM THE SECOND DEVICE WAS DEFLATED AND REMOVED. MANUAL COMPRESSION WAS HELD AT THE ACCESS SITE FOR APPROXIMATELY 10-15 MINUTES ON THE LEFT SIDE AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME WITH NO CLINICAL SEQUELA ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 F1220203

    Patients

    Seq Age Sex Outcome Treatment
    1