BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVX THROMBECTOMY SET

    MDR report key: 886428 · Received July 27, 2007

    Report

    Report Number
    2183460-2007-00008
    Event Type
    Other
    Date Received
    July 27, 2007
    Date of Event
    May 15, 2007
    Report Date
    July 27, 2007
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SITE STATED, THEY TRIED TO RETRACT THE CATHETER BUT IT BECAME STUCK, CATHETER CAME OUT ACCORDIONED AND BROKE. AN EMBOLECTOMY CATHETER WAS USED TO RETRIEVE THE REST OF THE BROKEN CATHETER. A FIVE INCH PIECE OF TWISTED AND DAMAGED CATHETER WAS ALL THAT WAS RETURNED FROM THE CUSTOMER SITE. ONLY THE PROXIMAL SADDLE IS ATTACHED TO THAT FIVE INCH PIECE. THE WINDOWS ARE TWISTED AND MANGLED THE DISTAL SADDLE, MARKER BAND, AND LOOP WERE NOT RETURNED. COULD NOT OPERATE THE THROMBECTOMY SET DUE TO ONLY FIVE INCHES OF IT BEING RETURNED. THE PRODUCT INFORMATION FOR USE STATES "DO NOT PULL THE CATHETER AGAINST ABNORMAL RESISTANCE. IF INCREASED RESISTANCE IS FELT WHEN REMOVING THE CATHETER, REMOVE THE CATHETER TOGETHER WITH THE SHEATH OR GUIDE CATHETER AS A UNIT TO PREVENT POSSIBLE TIP SEPARATION." THE EVENT CONSISTS OF TIP SEPARATION IN AN AV ACCESS GRAFT RECOVERED WITH AN EMBOLECTOMY CATHETER WITH NO FURTHER COMPLICATIONS OR SEQUELAE. THE EVENT WAS CAUSED BY REMOVING THE CATHETER AGAINST RESISTANCE IN CONTRADICTION THE LABELING INSTRUCTIONS TO REMOVE THE CATHETER TOGETHER WITH THE SHEATH OR GUIDE CATHETER AS A UNIT TO PREVENT POSSIBLE TIP SEPARATION. THE OPERATOR HAS BEEN REMINDED OF THE LABELING INSTRUCTIONS.

    Description of Event or Problem · 1

    WHILE USING AJ, DR. FELT RESISTANCE AND TRIED TO RETRACT THE CATHETER, BUT THE CATHETER WOULDN'T MOVE, TRIED PULLING WIRE BUT IT WAS STUCK. CATHETER CAME OUT ACCORDIONED AND BROKE. USED AN EMBOLECTOMY CATHETER TO RETRIEVE THE REST OF THE CATHETER. DIDN'T SAVE THE WHOLE CATHETER I'M SENDING IN ONLY 6" OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVX THROMBECTOMY SET ULTRA AVX DXE POSSIS MEDICAL, INC. ULTRA AVX 73350

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention