BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2970842 · Received February 21, 2013

    Report

    Report Number
    3004939290-2013-00053
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE CARTRIDGE WAS ENGAGED TO THE HANDLE. THE PROCEDURAL SHEATH WAS PULLED BACK AGAINST THE DISTAL END OF THE SHUTTLE. THE SEALANT WAS FLUSH WITH THE DISTAL END OF THE SHUTTLE. THE PROXIMAL SEALANT WAS SWELLING AND COMPRESSING AGAINST THE SHUTTLE CARTRIDGE. THE SHUTTLE CARTRIDGE TUBING WAS DISSECTED TO EXPOSE THE SEALANT AND AT THAT TIME IT WAS CONFIRMED THAT THE ADVANCER TUBE WAS INSIDE THE SHUTTLE CARTRIDGE. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE REPORTED EVENT COULD HAVE BEEN FROM AN INCOMPLETE ENGAGEMENT OF THE ADVANCER TUBE. THE REVIEW OF THE LHR (LOT F1232502) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI DISTRIBUTOR THAT A (B)(6) MALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE COMMON FEMORAL BELOW THE INGUINAL LIGAMENT VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH 3,500 UNITS OF HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM AT THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 7MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PHYSICIAN DID NOT SEE THE WHITE ADVANCER TUBE WHEN HE RETRACED AND ENGAGED THE SHUTTLE TO THE BLACK HANDLE. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO APPROXIMATELY 15 MINUTES OF MANUAL COMPRESSION AND A FEMOSTOP WAS APPLIED FOR AN HOUR PER THE HOSPITAL'S PROTOCOL. THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY ((B)(6) 2013) PER THE HOSPITAL'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75557 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1232502

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ORAL ANTIBIOTICS| 3,500 UNITS OF HEPARIN