BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3191915 · Received June 27, 2013

    Report

    Report Number
    3004939290-2013-00161
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 7, 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 CONCLUSIVELY DETERMINED. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT DURING PULLBACK OF THE BALLOON TOWARDS THE ARTERIOTOMY, PLAQUE BROKE FREE WHICH TRAVELED DOWNSTREAM AND CAUSED THE OCCLUSION. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON AN UNKNOWN DATE. ACCESS WAS OBTAINED VIA AN ANTEGRADE APPROACH. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED. A BUDDY WIRE (GUIDE WIRE) WAS USED. 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 THE PHYSICIAN FELT "STRONG" RESISTANCE DURING PULLBACK TOWARDS THE ARTERIOTOMY. THE PHYSICIAN KEPT PULLING UNTIL THE DEVICE PULLED FREE. AT THIS POINT THE PHYSICIAN DID NOT FEEL COMFORTABLE DEPLOYING THE DEVICE THEREFORE THE PHYSICIAN DECIDED TO CONVERT TO MANUAL COMPRESSION (DURATION UNKNOWN). THE BALLOON WAS NOT RUPTURED AND THE SEALANT WAS NOT DEPLOYED. FOLLOWING MANUAL COMPRESSION, THE PATIENT'S PEDAL PULSES WERE DIMINISHED AND THE LEG WHERE ACCESS WAS OBTAINED BEGAN TO DISCOLOR. THE PHYSICIAN DECIDED TO ACCESS THE PATIENT'S GROIN CONTRA LATERALLY AND ATTEMPT TO INTERVENE IF NECESSARY. THE PHYSICIAN FOUND OCCLUSIONS IN THE PROXIMAL AND DISTAL SFA (SUPERFICIAL FEMORAL ARTERY). THE PHYSICIAN ASPIRATED WHAT APPEARED TO BE PLAQUE FROM THE DISTAL SFA/POPLITEAL AND STENTED PROXIMAL SFA. THE PHYSICIAN REPORTED THAT HE BELIEVES THAT DURING PULLBACK OF THE BALLOON TOWARDS THE ARTERIOTOMY, PLAQUE BROKE FREE WHICH TRAVELED DOWNSTREAM AND CAUSED THE OCCLUSION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292896 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R