BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853477 · Received November 30, 2012

    Report

    Report Number
    3004939290-2012-00447
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE WAS ENGAGED TO THE HANDLE. THE SEALANT SLEEVE WAS DISPLACED, LOCATED 9MM FROM THE DISTAL END OF THE SHUTTLE CARTRIDGE. WHEN AN ATTEMPT WAS MADE TO DEPLOY THE SHUTTLE, SIGNIFICANT RESISTANCE WAS NOTED AND THE SHUTTLE DID NOT MOVE. A SMALL PIECE OF SEALANT WAS OBSERVED ADHERING TO THE POLYIMIDE SHAFT AND THE ADVANCER TUBE WAS ABUTTING THE SEALANT. THE SHUTTLE ASSEMBLY STARTED TO FREE UP WHEN THE SEALANT WAS HYDRATED. SHUTTLE DOWN PROCEDURE WAS SIMULATED AND THE ADVANCER TUBE WAS ABLE TO PROPERLY ENGAGE THE TAMP LOCKS. THE CATHETER, SHUTTLE CARTRIDGE AND INTRODUCER SHEATH WERE INSPECTED FOR ANOMALIES THAT MAY HAVE OBSTRUCTED THE DEVICE PATH DURING DEPLOYMENT. NO ANOMALIES WERE OBSERVED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE REPORTED FAILURE TO DEPLOY COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1218006) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1218006) 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 DISTRIBUTOR THAT A (B)(6) MALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 6F ARROW SHEATH. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PEG (SEALANT) STAYED IN THE SHEATH AND FAILED TO DEPLOY IN THE ARTERY. THE PATIENT WAS CONVERTED TO APPROXIMATELY 15 MINUTES OF MANUAL COMPRESSION AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1218006

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ASPIRIN| PLAVIX