BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3191914 · Received June 27, 2013

    Report

    Report Number
    3004939290-2013-00163
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 F1309403) 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) UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON 06/04/13. AN ANGIOPLASTY WAS PERFORMED WITH 2 BALLOON DILATATIONS AND 2 STENTS. PRE- AND POST-INTERVENTION, AN IVUS (INTRAVASCULAR ULTRASOUND) WAS PERFORMED. ACCESS WAS OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX AND PLAVIX. THE ACT (ACTIVATING CLOTTING TIME) MEASUREMENT WAS 289 SECONDS. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 8MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED A MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT AFTER THE "SWELL STEP", THE DEVICE WAS LAID DOWN FOR 90 SECONDS THEN THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT'S RIGHT GROIN/ACCESS SITE LOOKED "PUFFY" DURING THE SWELL PERIOD. FIRM VENOUS PRESSURE WAS HELD AT THE ACCESS SITE FOR 3 MINUTES. THE PATIENT'S GROIN APPEARED TO BE "FINE" WHILE THE STERILE DRAPE WAS IN PLACE. AFTER THE DRAPE HAD BEEN REMOVED FROM THE PATIENT, IT WAS APPARENT THAT THE PATIENT HAD DEVELOPED A HEMATOMA LESS THAN 6CM IN SIZE. THE HEMATOMA WAS LOCATED JUST BELOW AND MEDIAL TO THE PUNCTURE SITE. FIRM ARTERIAL PRESSURE WAS HELD ON THE HEMATOMA FOR 15 MINUTES. THE GROIN WAS STABILIZED AND THE HEMATOMA WAS NOTED TO BE GETTING SOFTER. THE PATIENT WAS MOVED FROM THE PROCEDURAL TABLE TO A STRETCHER AND A FEMOSTOP WAS PLACED AS A PRECAUTION, BECAUSE THE PATIENT WAS OVERWEIGHT AND HAD A LARGE TISSUE BED. THE PATIENT WAS HOSPITALIZED AND THE DISCHARGED DATE IS UNKNOWN. THE PATIENT'S HOSPITALIZATION WAS NOT MYNX DEVICE/MYNX PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294232 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1309403

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PLAVIX| ANGIOMAX