BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN BALLOON DILATATION CATHETER

    MDR report key: 1221996 · Received November 6, 2008

    Report

    Report Number
    2134265-2008-04239
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CENTRAL VENOUS ANGIOPLASTY PROCEDURE, A BALLOON DETACHED FROM A CATHETER INSIDE THE PT. THE LESION WAS LOCATED IN THE NON TORTUOUS SUBCLAVIAN. THE LESION WAS 95% STENOSED AND NOT CALCIFIED. THE VASCULAR ACCESS SITE WAS THE RIGHT ARM, VENOUS. THE PHYSICIAN ADVANCED THE ULTRA THIN DIAMOND 8 MM X 4 CM 6 FRENCH BALLOON TO THE LESION. THE BALLOON WAS INFLATED AT THE LESION 3 TIMES AT 6 ATM AND THE INDIVIDUAL INFLATION TIMES ARE UNK. UPON WITHDRAWAL, THE BALLOON SEPARATED FROM THE CATHETER. THE PHYSICIAN MADE A SEPARATE INCISION 4 CM PROXIMAL TO ANOTHER MFR'S SHEATH TO REMOVE THE BALLOON. THE BALLOON WAS OVER ANOTHER MFR'S GUIDE WIRE INSIDE THE PT. THE PHYSICIAN REMOVED BOTH THE BALLOON AND THE GUIDEWIRE SUCCESSFULLY. THE PT'S CURRENT STATUS IS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 11927708

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention TERUMO GLIDEWIRE 180 CM| TERUMO 6 FRENCH PINNACLE SHEATH