BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840175 · Received June 21, 2012

    Report

    Report Number
    3004939290-2012-00161
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 INFO PROVIDED. THE 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 VASCULAR CLOSURE SPECIALIST THAT A FEMALE PT UNDERWENT AN INTERVENTIONAL CAROTID PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 6F SHEATH (MODEL UNK). 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 WHILE THE BALLOON WAS INFLATED AND THE DEVICE WAS LAID DOWN, SLIGHT OOZING WAS NOTICED AT THE ACCESS SITE. PRESSURE WAS APPLIED AT THE ACCESS SITE, THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED FROM THE PT. AFTER A 5 MINUTE HOLD, THE PHYSICIAN CHECKED FOR HEMOSTASIS, AND THERE WAS SIGNIFICANT BLEEDING AT THE ACCESS SITE. ADDITIONAL COMPRESSION WAS HELD FOR 25 MINUTES, THEREAFTER HEMOSTASIS WAS ACHIEVED. THE PHYSICIAN CHECKED THE PT'S PULSES BY HAND AND DOPPLER AND DETERMINED THERE WAS GOOD FLOW TO THE PT'S FOOT. THE PHYSICIAN REPORTED THAT 3 HRS AFTER THE PROCEDURE (POST F/U) THE PT'S PULSES AND ACCESS SITE WERE GOOD. THE PT WAS GIVEN HEPARIN AND THE ACT WAS 304 AT THE TIME OF DEPLOYMENT. NO FEMORAL ANGIOGRAM WAS TAKEN PRIOR TO CLOSURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HEPARIN