BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3000716 · Received March 12, 2013

    Report

    Report Number
    3004939290-2013-00085
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1302201) 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 SALES PROFESSIONAL THAT A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT PROFUNDA VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH 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 FOLLOWING THE POST DEPLOYMENT HOLD OF 5 MINUTES, A 3CM X 3CM HEMATOMA DEVELOPED AT THE ACCESS SITE. MANUAL COMPRESSION WAS APPLIED AT THE ACCESS SITE FOR 5 MINUTES AT WHICH TIME THE HEMATOMA SEEMED TO SOFTEN AND RESOLVE ITSELF. A SANDBAG WAS PLACED ON THE GROIN AS AN ADDED PRECAUTION. WHEN THE PATIENT REACHED THE RECOVERY ROOM, THE HEMATOMA HAD RE-DEVELOPED THIS TIME THE SIZE OF THE HEMATOMA WAS APPROXIMATELY 4CM X 4CM. AN ADDITIONAL 10 MINUTES OF MANUAL COMPRESSION WERE APPLIED AT THE ACCESS SITE, FOLLOWED BY PLACEMENT OF A FEMOSTOP DEVICE. THE PATIENT WAS HOSPITALIZED FOR UNRELATED AND UNSPECIFIED REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102980 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1302201

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention HEPARIN