BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2011024 · Received March 8, 2011

    Report

    Report Number
    3004939290-2011-00022
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 11, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE SHUTTLE WAS ENGAGED TO THE HANDLE WITH THE SEALANT STILL IN MANUFACTURING POSITION. THE BALLOON WAS DETACHED AND SEPARATED FROM THE DEVICE. A RADIAL TEAR WAS OBSERVED IN THE BALLOON. ADDITIONALLY, THE BALLOON SHAFT WAS BENT. THE PROXIMAL BOND DID NOT SHOW ANY DAMAGE. BASED ON THE INVESTIGATION PERFORMED AND THE CONDITION OF THE RETURNED DEVICE, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1032406) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT A PERIPHERAL INTERVENTION PROCEDURE ON (B)(6) 2011. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY (CFA) VIA A 6F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM WAS TAKEN WHICH REVEALED THE ARTERY TO BE CALCIFIED. REPORTEDLY, THE MYNX DEVICE WAS USED PER IFU. IT WAS REPORTED THAT DUE TO THE CALCIFIED ARTERY, THE RADIOLOGY TECHNOLOGIST (RT) TRAINED TO THE MYNX CADENCE PROCEDURE, UTILIZED THE BUDDY WIRE TECHNIQUE AND INFLATED THE BALLOON USING THE 50/50 CONTRAST AND SALINE TO AID IN BETTER VISUALIZATION. FOLLOWING THE MYNX DEPLOYMENT AND SUBSEQUENT BALLOON DEFLATION, THE RT ENCOUNTERED DIFFICULTY REMOVING THE DEVICE FROM THE ADVANCER TUBE. THE DEVICE WAS EVENTUALLY PULLED OUT OF THE ADVANCER TUBE WITHOUT USE OF EXCESSIVE FORCE. UPON VISUAL INSPECTION OF THE DEVICE FOLLOWING REMOVAL, THE RT NOTICED THAT THE BALLOON WAS NOT ON THE CATHETER. THE RT IMMEDIATELY USED FLUOROSCOPY TO VISUALIZE THE CFA. THE RT WAS ABLE TO SEE THE MYNX BALLOON STILL FULL OF CONTRAST, FREE-FLOATING IN THE ARTERY. MANUAL COMPRESSION WAS IMMEDIATELY PERFORMED TO PREVENT THE BALLOON FROM POTENTIALLY MIGRATING DISTALLY INTO THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN, WHO INITIALLY PERFORMED THE PROCEDURE, ACCESSED THE OPPOSITE GROIN AREA CONTRALATERALLY THEN SNARED AND REMOVED THE BALLOON. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME THE FOLLOWING DAY PER HOSPITAL PROTOCOL WITHOUT FURTHER CLINICAL SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6701 F1032406

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention