BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIX COMPAK INFLATION SYRINGE KIT

    MDR report key: 2910052 · Received November 16, 2012

    Report

    Report Number
    9616662-2012-00044
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MERIT MEDICAL SYSTEMS LTD.
    Product Code
    DXT
    PMA / PMN Number
    K884913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION. THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. MERIT RECEIVED A COPY OF A FORM FDA 3500 MDR REPORT FROM THE USER FACILITY ON (B)(4) 2012 WHICH CONTAINS A PT IDENTIFIER NUMBER, THERE IS NO REPORT NUMBER ASSIGNED. MERIT RECEIVED ONE COPY OF A USER FACILITY REPORT (B)(4) FROM THE FDA ON (B)(4) 2012. MERIT BELIEVES BOTH REPORTS REFER TO THE SAME EVENT. (B)(6) WAS CONTACTED ON (B)(4) 2012 FOR ADDITIONAL INFORMATION ABOUT THE PROCEDURE BEING PERFORMED. (B)(6) DID NOT HAVE ANY ADDITIONAL INFORMATION TO PROVIDE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE THE DEVICE INFLATED BY ITSELF WHILE IN THE PT. THE CRANK MECHANISM FAILED AS WELL AS THE LOCK THAT DOESN'T ALLOW THE BALLOON TO BE INSUFFLATED UNLESS IT IS PUSHED. IT WAS REPORTED ON (B)(6) 2012 THAT THE DEVICE WAS CONTINUOUSLY USED THROUGHOUT THE CASE. THE STENT WAS DEPLOYED WITHOUT PROBLEMS AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIX COMPAK INFLATION SYRINGE KIT INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT MERIT MEDICAL SYSTEMS LTD. K357310

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR STENT