BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2822382 · Received June 13, 2012

    Report

    Report Number
    3004939290-2012-00137
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    May 13, 2012
    Report Date
    May 16, 2012
    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 INFO PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1210303) INDICATED THAT THE MYNX LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY ACI VASCULAR CLOSURE SPECIALIST THAT A (B)(6) FEMALE PATIENT WITH HISTORY OF HTN, CAD, AND RENAL CA, UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. THE PT RECEIVED 3 STENTS. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY 1-1.5 CM DISTAL TO THE IEA, VIA A 7F TERUMO SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. A 50/50 CONTRAST WAS USED. FOLLOWING THE PROCEDURE, THE PHYSICIAN CHOSE THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F FOR FEMORAL ARTERIAL CLOSURE. THE PHYSICIAN, WHO WAS IN TRAINING WITH THE MYNX DEVICE, CLOSED THE ACCESS SITE UNDER THE ACI¿S VASCULAR CLOSURE SPECIALIST AND REGIONAL SALES MANAGER¿S SUPERVISION. IT WAS REPORTED THAT THE ACCESS SITE WAS CLOSED WITH GOOD TECHNIQUE. THE PT DID NOT HAVE A HEMATOMA UPON DISCHARGE ON (B)(6) 2012. THE PT REMAINED NORMOTENSIVE WITH ANTIHYPERTENSIVES. ON (B)(6) 2012 THE PT STATED ¿A KNOT STARTED TO FORM AND STARTED GETTING BIGGER¿. THE PT COMPLAINED OF ABDOMINAL AND CHEST PAIN. A CT SCAN SHOWED A ¿MODERATE SIZED RIGHT GROIN HEMATOMA WHICH TRACED RETROGRADE INTO THE PELVIS AND SURROUNDED THE ILIAC VEIN¿. THE HEMATOMA WAS DESCRIBED AS THE SIZE OF A BASEBALL (OVER 6CM). LEUKOCYTOSIS TO 22K. BACTRIM DS WAS STARTED FOR TEN DAYS. NO PSEUDOANEURYSM WAS SEEN WITH THE IMAGING. THE HGB WAS 10.9 ON (B)(6) 2012 AND HGB WAS 9.8 ON (B)(6) 2012. THERE WAS PURULENT DRAINAGE FROM THE PT¿S GROIN, AND THE PT WAS STARTED ON IV VANCOMYCIN (B)(6) 2012. THE PHYSICIAN MADE AN INCISION AND REMOVED THE HEMATOMA. THE PT¿S GROIN WAS OPEN AND WAS PACKED. THE PT WAS SCHEDULED TO BE DISCHARGED ON (B)(6) 2012. THE BLOOD CULTURE WAS NEGATIVE. WOUND CULTURE WAS NEGATIVE FOR STAPHYLOCOCCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1210303

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization PRASUGREL| ASA| INTEGRILLIN| IV VANCOMYCIN| BACTRIM DS| ANGIOMAX