BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2855129 · Received December 3, 2012

    Report

    Report Number
    3004939290-2012-00448
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1229102) 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 CLINICAL SPECIALIST THAT A MALE PATIENT WHO IS IN HIS 60'S UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY (ANTI GRADE) VIA A 6F. THERE WERE AT "LEAST 2 SHEATH EXCHANGES". PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON LOST PRESSURE DURING PULL BACK. THE DEVICE WAS REMOVED AND A SECOND MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F WAS DEPLOYED SUCCESSFULLY. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1229102

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HEPARIN