BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2962268 · Received February 14, 2013

    Report

    Report Number
    3004939290-2013-00049
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI CLINICAL SPECIALIST THAT A MALE PATIENT UNDERWENT A RIGHT AND LEFT DIAGNOSTIC CORONARY HEART CATHETERIZATION PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED VIA A 6F SHEATH (UNKNOWN MODEL). THE PATIENT HAS A HISTORY OF PULMONARY HYPERTENSION, DIABETES AND DIALYSIS. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE ON THE LEFT FEMORAL ARTERY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY WITH NO CLINICAL SEQUELA NOTED. IT WAS REPORTED THAT THE FOLLOWING DAY THE PATIENT WAS BEARING DOWN FOR A BOWEL MOVEMENT AND HE "FELT SOMETHING POP." THIS RESULTED IN A LARGE HEMATOMA (SIZE UNKNOWN) AND THE PATIENT WAS RUSHED TO THE MEDICAL CENTER WHERE A SURGICAL PROCEDURE WAS PERFORMED TO REPAIR THE ARTERIOTOMY. IT WAS ALSO REPORTED THAT THE "SEALANT WAS NOT FOUND". THE PATIENT WAS REPORTED AS OK. AT THIS TIME IT IS UNKNOWN IF THE PATIENT HAS BEEN DISCHARGED FROM THE MEDICAL CENTER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64399 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R