BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3112985 · Received May 15, 2013

    Report

    Report Number
    3004939290-2013-00125
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT TO INFLATE THE BALLOON FROM THE RETURNED DEVICE WITH WATER REVEALED A LEAK IN THE BALLOON. VISUAL INSPECTION AT HIGH MAGNIFICATION CONFIRMED THAT THE SOURCE OF THE LEAK WAS A PIN HOLE IN THE BALLOON, APPROXIMATELY 8 MM FROM THE BALLOON PROXIMAL TIP. DAMAGE WAS OBSERVED AT THE DISTAL TIP OF THE INTRODUCER SHEATH. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE OF THE PIN HOLE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1301801) INDICATED THAT THE DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE SUPERFICIAL FEMORAL ARTERY. PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE HE WAS ATTEMPTING TO INSERT THE DEVICE INTO THE PROCEDURAL SHEATH, SO THE PHYSICIAN INSERTED A 0.38MM GUIDE WIRE, AND THEN INSERTED THE DEVICE INTO THE PROCEDURAL SHEATH BESIDE THE GUIDE WIRE (STILL WITH SOME RESISTANCE). ONCE THE PHYSICIAN GOT THE DEVICE INSERTED UP TO THE WHITE MARKER HE REMOVED THE GUIDE WIRE, INFLATED THE BALLOON, PULLED BACK UNTIL HE FELT THE BALLOON FIRST ABUTTING THE TIP OF THE SHEATH BUT THEN THE BALLOON PULLED THROUGH THE ARTERIOTOMY AND ACCESS WAS LOST. THE PHYSICIAN IMMEDIATELY CONVERTED THE PATIENT TO 5 MINUTES OF MANUAL COMPRESSION AND PLACED A FEMOSTOP AT THE ACCESS SITE FOR 2 HOURS TO ACHIEVE HEMOSTASIS. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO CLINICAL SEQUELA NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214619 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1301801

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ANGIOMAX