BEUDAMED
    FDA Adverse Event Other Summary report: N

    WEDGE PRESSURE BALLOON CATHETER

    MDR report key: 371082 · Received January 10, 2002

    Report

    Report Number
    2243801-2002-00031
    Event Type
    Other
    Date Received
    January 10, 2002
    Date of Event
    December 14, 2001
    Report Date
    January 10, 2002
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RETURN REASON: CATHETER WAS FLUSHED AND UPON INSERTION INTO THE SHEATH THE TIP OF THE CATHETER BROKE OFF. TIP OF CATHETER WAS RETRIEVED BY THE DOCTOR WITH A HEMOSTAT. NO PT INJURY REPORTED. ANALYSIS: INVESTIGATION COULD NOT BE COMPLETED. BREAK ORIGIN IS UNKNOWN. CATHETER WAS NOT RETURNED TO DO A COMPLETE INVESTIGATION. HISTORY SHOWS THREE OTHER DEFECTS OF THIS NATURE IN 2001. IT IS REPORTED THAT PVC TUBING IS NOT AS STABLE AS OTHER TUBING TYPES AND IS AFFECTED MORE BY OVER-HEATING, CHEMICALS AND/OR ADHESIVES WHICH CAN MAKE THE MATERIAL BRITTLE AND EASIER TO BREAK. IT IS THE MATERIAL NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEDGE PRESSURE BALLOON CATHETER FLOW-DIRECTED BALLOON CATHETER DYG B. BRAUN MEDICAL, INC. WP-110-7 0060253051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention