BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3230199 · Received July 16, 2013

    Report

    Report Number
    3004939290-2013-00177
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 F1312001) 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 SALES PROFESSIONAL THAT A (B)(6) YEAR OLD, FEMALE, PATIENT, PRESENTED TO THE HOSPITAL WITH CLASSIC ANGINA AND SYMPTOMS OF MI (MYOCARDIAL INFARCTION). THE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. THE PATIENT WAS TREATED AND STENTED FOR CAD (CORONARY ARTERY DISEASE). ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F TERUMO SHEATH (SIZE UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX, PLAVIX, AND ASPIRIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 6.5MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED PER THE IFU. ONCE THE DEVICE WAS REMOVED FROM THE PATIENT, PRESSURE WAS HELD AT THE ACCESS SITE PER THE IFU, AND THEN A HEMATOMA (SIZE UNKNOWN) WAS NOTED AT THE ACCESS SITE. THIRTY MINUTES OF MANUAL PRESSURE WAS APPLIED TO THE HEMATOMA. THEN, A FEMOSTOP WAS PLACED PROPHYLACTICALLY TO REDUCE THE RISK OF FURTHER BLEEDING. HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS KEPT IN THE HOSPITAL DUE TO EXISTING PNEUMONIA. THE PATIENT PRESENTED TO THE CATH LAB ON (B)(6) 2013, WITH ACTIVE BLEEDING AT THE FEMORAL ACCESS SITE. THE DEPLOYING PHYSICIAN ASSESSED THE SITE AND IMMEDIATELY SENT THE PATIENT TO SURGERY. THE SURGEON NOTED THAT THE BLEEDING WAS THOUGHT TO BE FROM A RUPTURED PSEUDOANEURYSM WHICH REQUIRED AN OPEN SURGICAL INCISION TO REPAIR. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328852 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1312001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O| R PLAVIX| ANGIOMAX| ASPIRIN