BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2945667 · Received February 6, 2013

    Report

    Report Number
    3004939290-2013-00035
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE REVIEW OF THE LHR (LOT F1232003) 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 VASCULAR CLOSURE SPECIALIST THAT A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2013. ANTEGRADE ACCESS WAS OBTAINED WITH ULTRASOUND AT THE RIGHT COMMON FEMORAL ARTERY VIA A 6F TERUMO SHEATH. PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. 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 IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED PER THE IFU. AFTER THE DEVICE DEPLOYMENT THE ACCESS SITE WAS SOFT AND WITHOUT ANY BRUISING OR OOZING. THE PATIENT DENIED ANY PAIN OR DISCOMFORT. THE PATIENT REMAINED FLAT FOR 2 HOURS POST CLOSURE. THEN THE PATIENT WAS AMBULATED AND HER PRESSURE SUBSEQUENTLY DROPPED. A CT SCAN REVEALED A RETROPERITONEAL BLEED. MANUAL PRESSURE WAS APPLIED AND HELD AT THE ACCESS SITE FOR 30 MINUTES. THE PATIENT'S HGB DROPPED FROM 13GM TO 10GM (WITH NO BLOOD PRODUCTS GIVEN). THE PATIENT WAS REPORTED AS HOSPITALIZED DUE TO THE MYNX PROCEDURE AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 WITH NO CLINICAL SEQUELA NOTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51102 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1232003

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O HEPARIN