BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2962269 · Received February 14, 2013

    Report

    Report Number
    3004939290-2013-00050
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 22, 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 F1235202) 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 VASCULAR CLOSURE SPECIALIST THAT A (B)(6) MALE PATIENT WITH HISTORY OF CHEST PAIN WENT INTO THE HOSPITAL ON (B)(6) 13 FOR A STEMI WITH STENTS TO HIS RCA (RIGHT CORONARY ARTERY) AND UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON THE SAME DAY. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F TERUMO SHEATH. PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX AND PLAVIX. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM PRESENT AND THE VESSEL SIZE APPROXIMATELY 7MM. 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 DEVICE WAS DEPLOYED PER THE IFU. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. THREE DAYS LATER THE PATIENT PRESENTED TO THE E.R. WITH FLU LIKE SYMPTOMS, WHEREUPON HIS RIGHT GROIN SITE WAS FOUND TO HAVE A 6CM X 6CM HEMATOMA. A CT SCAN WAS ORDERED WHICH CONFIRMED THE HEMATOMA AND BLOOD IN THE RETROPERITONEAL SPACE. THE STAFF REPORTED THAT THIS WAS NOT A MULTIPLE STICK CASE AND THAT THE TECHNIQUE AND CLOSE WAS WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66062 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1235202

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other PLAVIX| ANGIOMAX