BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIB CATHETER

    MDR report key: 289200 · Received August 4, 2000

    Report

    Report Number
    1318694-2000-00007
    Event Type
    Other
    Date Received
    August 4, 2000
    Date of Event
    July 18, 2000
    Report Date
    August 4, 2000
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PERIPHERAL TRANSLUMINAL ANGIOPLASTY ("PTA") CATHETER WAS USED TO PERFORM A DEPLOYMENT OF A CORDIS STENT ON A 13 YEAR OLD PT. THE BALLOON BURST CAUSED BY A PIN HOLE WHICH WAS INADVERTENTLY CREATED WHEN THE STENT WAS CRIMPED ONTO THE BALLOON. THE BALLOON WOULD NOT DEPLOY THE STENT. AN INTELLAFLATOR WAS USED TO GET THE BALLOON TO PRESSURE, WHICH WERE WITHIN THE LIMITS ACCORDING TO HOSP OFFICIALS. THE INNER BALLOON WAS USED TO DEPLOY THE STENT IN THE DESCENDING AORTA. THE CATHETER WAS REMOVED AS ONE UNIT LEAVING A HEMATOMA AT THE SITE. THE PT IS DOING FINE AND WILL BE RESCHEDULED FOR STENTING AT ANOTHER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIB CATHETER PTA CATHETER LIT NUMED, INC. 420 BIB-0612

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other STENT.