BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIX COMPAK INFLATION SYRINGE KIT

    MDR report key: 2060916 · Received March 14, 2011

    Report

    Report Number
    9616662-2011-00022
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K993057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER IS NOT CERTAIN WHICH LOT THE SUSPECT DEVICE CAME FROM. OTHER POSSIBLE LOT NUMBERS REPORTED BY THE CUSTOMER INCLUDE: W715661, DEVICE MANUFACTURE DATE - 05/2009, EXPIRATION DATE - 05/26/2012. K152527, DEVICE MANUFACTURE DATE - 07/2010, EXPIRATION DATE -07/31/2013. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. EVALUATION: CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE HEMOSTASIS VALVE BROKE DURING AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. THIS REQUIRED THE REMOVAL OF THE CATHETER AND THE BALLOON/STENT IN ORDER TO EXCHANGE THE HEMOSTASIS VALVE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIX COMPAK INFLATION SYRINGE KIT INJECTOR AND SYRINGE, ANGIOGRAPHIC DTL MERIT MEDICAL SYSTEMS, INC. K114839

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE CONTRAST| INTERVENTIONAL WIRE| CATHETER| BALLOON/STENT