BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 3083385 · Received April 29, 2013

    Report

    Report Number
    3004939290-2013-00104
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 SALES PROFESSIONAL THAT A FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY ANGIOPLASTY PROCEDURE SOMETIME DURING (B)(6) 2013. ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY. PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX, PLAVIX AND ASA. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SORENESS IN HER RIGHT GROIN. THERE WAS NO HEMATOMA VISIBLE OR FELT BY HAND. AN ULTRASOUND WAS PERFORMED WHICH REVEALED AN AV FISTULA. THE PHYSICIAN REPORTED THAT HE IS NOT SURE IF THE AV FISTULA WAS CAUSED BY THE ACCESS. THE AV FISTULA WAS SUCCESSFULLY TREATED WITH A THROMBIN INJECTION IN THE IR DEPARTMENT (INTERVENTIONAL RADIOLOGY DEPARTMENT). THE PATIENT WAS HOSPITALIZED PER STANDARD HOSPITAL PROTOCOL FOR THE CORONARY ANGIOPLASTY PROCEDURE. THE DISCHARGE DATE WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183576 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R PLAVIX| ANGIOMAX| ASA