BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW. 035 MC J3MM 150CM TEF AMP

    MDR report key: 795689 · Received December 9, 2004

    Report

    Report Number
    9616099-2004-00603
    Event Type
    Malfunction
    Date Received
    December 9, 2004
    Date of Event
    November 18, 2004
    Report Date
    December 8, 2004
    Manufacturer
    CORDIS CORP (MIAMI)
    Product Code
    MKI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    GUIDEWIRE TIP BREAKAGE AND SEPARATION. THE REPORT FROM THE AFFILIATE INDICATED THAT: THE PATIENT WAS TO UNDERGO AN EMBOLIZATION OF THE HEPATIC ARTERY IN THE CELIAC TRUNK. THE PHYSICIAN PLACED THE GUIDECATHETER INTO THE CATHETER SHEATH INTRODUCER AND FELT RESISTANCE AT THE TIP; SHE USED A SMALL AMOUNT OF FORCE AND FINISHED ADVANCING THE CATHETER OVER THE WIRE. AFTER THAT, THE WIRE WAS REMOVED BUT IT WAS NOTED ON PICTURES THAT PART OF THE WIRE REMAINED INSIDE THE CATHETER IN THE PATIENT. THE CATHETER WAS REMOVED AND THE COIL TIP OF THE WIRE WAS FOUND STUCK INSIDE THE CATHETER; IT HAD COMPLETELY SEPARATED FROM THE CORE. THE PHYSICIAN SPECULATED THAT PUSHING AGAINST THE RESISTANCE PUSHED THE WIRE TIP INTO THE TIP OF THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SYSTEM, AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGW. 035 MC J3MM 150CM TEF AMP CARDIOLOGY WIRES & METALS MKI CORDIS CORP (MIAMI) NA F0804874

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR CSI 5F AVANTI GUIDECATHETER,| CATHETER SHEATH INTRODUCER