BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840294 · Received April 19, 2012

    Report

    Report Number
    3004939290-2012-00078
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED IN A SMALL BIOHAZARD BAG, DISASSEMBLED, WITH THE CATHETER LUMEN AND THE SHUTTLE CARTRIDGE SEVERELY KINKED. THE DEVICE WAS RECEIVED WITH A SEGMENT OF THE SHUTTLE CARTRIDGE TORN 18 MM FROM THE DISTAL END. THE SEALANT WAS FOUND INSIDE THE TORN CARTRIDGE SEGMENT. BLOOD WAS OBSERVED ON FULL LENGTH OF THE SEALANT. BOTH THE INTRODUCER SHEATH AND THE ADVANCER TUBE HAD SIGNIFICANT DAMAGES. THIS EVIDENCE SUGGESTS THAT THE DEVICE MAY HAVE BEEN MANIPULATED. IT IS UNKNOWN WHETHER THE DAMAGES ON THE DEVICE WERE DUE TO POST-PROCEDURAL MANIPULATION OR DURING TRANSIT TO ACCESS CLOSURE. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1204402) 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 CLINICAL SPECIALIST THAT A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY WITH A 5F PINNACLE TERUMO SHEATH. PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED NO EVIDENCE OF CALCIUM OR PVD IN THE VICINITY OF THE PUNCTURE SITE. POST PROCEDURE, THE PHYSICIAN, WHO IS IN TRAINING WITH THE MYNX, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT AFTER SHUTTLING DOWN TO THE HARD STOP, THE PHYSICIAN RETRACTED THE SHEATH ACCORDING TO THE IFU, AND THE ADVANCER TUBE DID NOT ENGAGE. THE PHYSICIAN ELECTED TO DEFLATE THE BALLOON AND REMOVED THE DEVICE. THE PATIENT WAS SUBSEQUENTLY CONVERTED TO 10 MINUTES OF MANUAL COMPRESSION WITH NO ADVERSE EVENT OR FURTHER COMPLICATION. THE PATIENT WAS DISCHARGED HOME WITH NO CLINICAL SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB ACCESSCLOSURE, INC. MX5001 F1204402

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR