BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX ACE (5F/6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 5438542 · Received February 16, 2016

    Report

    Report Number
    3004939290-2016-00033
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 22, 2016
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED TO ACCESSCLOSURE INC. (A CARDINAL HEALTH COMPANY), VISUALLY INSPECTED AND THE INVESTIGATION CONFIRMED THE FAILURE. INVESTIGATION REVEALED THAT BUTTON NUMBER # 1 HAD BEEN FULLY DEPRESSED BUT THE SLED SUBASSEMBLY WAS STUCK WITHIN THE HANDLE HOUSING. SUBSEQUENT TO DISASSEMBLING THE HANDLE HOUSING, IT WAS OBSERVED THAT ONE OF THE FRAME'S SNAP-FIT TAB WAS NOT PROPERLY ENGAGED AND CAME INTO CONTACT WITH THE INSIDE WALL OF THE HOUSING PREVENTING MOVEMENT OF THE SLED SUBASSEMBLY. THE LOCKING FEATURE WAS SNAPPED BACK TO ITS PROPER POSITION AND THE PRONG WAS ABLE TO FULLY ENGAGE. THE SLED SUBASSEMBLY WAS ASSEMBLED INTO THE HANDLE HOUSING AND THE SUBASSEMBLY MOVED FREELY AND PERFORMED AS INTENDED. THE REVIEW OF THE LHR (F1524301) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED EVENT WAS THAT THE SNAP FIT LOCKING FEATURE WAS NOT PROPERLY ENGAGED PREVENTING THE SLED ASSEMBLY FROM SLIDING FORWARD. THIS ISSUE IS BEING ADDRESSED THROUGH CAPA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRESSING BUTTON # 1 OF THE MYNX ACE VASCULAR CLOSURE DEVICE TO DEPLOY THE SEALANT, THE HANDLE WOULD NOT SLIDE BACK. THE PHYSICIAN MADE SURE THAT THE BUTTON #1 WAS FULLY DEPRESSED; HOWEVER, THE HANDLE WOULD STILL NOT SLIDE BACK. THE BALLOON WAS DEFLATED AND MANUAL COMPRESSION WAS APPLIED FOR 20 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO KNOWN PATIENT OR TECHNIQUE DRIVEN REASON FOR THE HANDLE NOT BEING ABLE TO SLIDE BACK. IT IS UNKNOWN WHETHER OR NOT THE PATIENT'S HOSPITALIZATION WAS PROLONGED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. STICK LOCATION: MEDIUM SHEATH SIZE: 5F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96465 MYNX ACE (5F/6F/7F) VASCULAR CLOSURE DEVICE MGB MGB CARDINAL HEALTH MX6740 F1524301

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR