BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    MDR report key: 4192511 · Received October 22, 2014

    Report

    Report Number
    3004939290-2014-00613
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    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 WAS NOT PERFORMED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE REVIEW OF THE LHR (LOT F1422003) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. 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. UDI NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: 6F 10CM PINNACLE SHEATH WAS USED WHICH WAS THEN EXCHANGED WITH THE ACE INTRODUCER. WHEN THE PHYSICIAN PULLED BACK TO THE ARTERIOTOMY, PRESSED BUTTON #1, THE TRAY SLID FORWARD, THEN THE PHYSICIAN PRESSED BUTTON #2 AND BUTTON #2 WENT DOWN "A LITTLE BIT" BUT DIDN'T DEPRESS ALL THE WAY. THE PHYSICIAN FELT THAT THE SEALANT DIDN'T DEPLOY AND THE PHYSICIAN DEFLATED THE BALLOON AND PULLED OUT EVERYTHING. MANUAL COMPRESSION WAS APPLIED FOR 25 MINUTES. THE PATIENT WAS NOT HOSPITALIZED. PROCEDURE TYPE: INTERVENTION PERIPHERAL STICK LOCATION: COMMON FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672772 MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6740 F1422003

    Patients

    Seq Age Sex Outcome Treatment
    1 5,000 UNITS OF HEPARIN