BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2911606 · Received January 11, 2013

    Report

    Report Number
    3004939290-2013-00006
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 F1229301) 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 A STEMI INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE FEMORAL HEAD VIA A 6/7F SHEATH. PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH HEPARIN AND INTEGRILIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. THE DEVICE WAS PREPPED AND DEPLOYED PER THE IFU. IT WAS REPORTED THAT DURING DEPLOYMENT THE "DEVICE GOT HUNG UP AND THE PHYSICIAN COULDN'T RETRACT THE SHEATH". THE DEPLOYMENT WAS ABORTED AND THE DEVICE WAS REMOVED. THE PATIENT WAS CONVERTED TO APPROXIMATELY 20 MINUTES OF MANUAL COMPRESSION IN THE LAB AND THEN 30 ADDITIONAL MINUTES ON THE FLOOR. THE PATIENT WAS ALSO GIVEN PROTAMINE "TO REVERSE THE BLEEDING". NO FURTHER COMPLICATIONS WERE NOTED. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18111 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1229301

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention INTEGRILIN| HEPARIN| PROTAMINE