BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT ASPIRATION CAHTETER

    MDR report key: 2860620 · Received December 5, 2012

    Report

    Report Number
    1721504-2012-00208
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXE
    PMA / PMN Number
    K100569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED FOR LOT SPECIFIC INFORMATION AS THE LOT NUMBER WAS NOT PROVIDED. THE RETURNED DEVICE WAS VISUALLY EXAMINED AND X-RAYED. THE GUIDE CATHETER, GUIDE WIRE, AND ASPIRATION CATHETER WERE STUCK TOGETHER. THE GUIDE WIRE CORE WIRE WAS BROKEN. WHILE REMOVING THE ASPIRATION CATHETER FROM THE GUIDE CATHETER, A TEAR APPROXIMATELY 5CM TO THE EXCHANGE LUMEN OF THE ASPIRATION CATHETER WAS CAUSED BY THE LOOPED AND BROKEN GUIDE WIRE. ROOT CAUSE OF THE DAMAGE IS CONSISTENT WITH THE ASPIRATION CATHETER BEING EXTENDED BEYOND THE GUIDE CATHETER TIP FAR ENOUGH TO ALLOW THE GUIDE WIRE TO 'LOOP' OR DEVELOP 'SLACK' AT THE PROXIMAL END OF THE EXCHANGE LUMEN AND THEN PULLED BACK INTO THE GUIDE CATHETER. METHOD: ACTUAL DEVICE EVALUATED. VISUAL INSPECTION. RADIOGRAPHIC INSPECTION. RESULTS: INTEROPERABILITY PROBLEM. DEFORMATION PROBLEM. CONCLUSIONS: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AFTER THE 4TH OR 5TH PASS THE ASPIRATION CATHETER AND GUIDE WIRE GOT SUCK IN THE GUIDE CATHETER. THE ASPIRATION CATHETER WAS DAMAGED WHILE ATTEMPTING TO REMOVE FROM GUIDE CATHETER. THE PHYSICIAN REMOVED THE DEVICES AND REPLACED THE GUIDE WIRE AND GUIDE CATHETER. NO LOT NUMBER WAS PROVIDED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT ASPIRATION CAHTETER CATHETER, EMBOLECTOMY DXE MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER - CORDIS BRITE TIP 6FR| GUIDE WIRE