BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN BALLOON DILATATION CATHETER

    MDR report key: 1032349 · Received April 22, 2008

    Report

    Report Number
    2134265-2008-01153
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON DETACHMENT OCCURRED. THE ANATOMY WAS REPORTED TO BE CALCIFIED. THERE WAS NO DIFFICULTY WITH ADVANCEMENT OR INFLATION OF THE 10 X 5MM ULTRATHIN DIAMOND BALLOON. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNKNOWN. DURING REMOVAL THROUGH THE 6F INTRODUCER SHEATH, THE BALLOON DETACHED FROM THE CATHETER. THE PATIENT ENDED UP GOING TO SURGERY AND HAVING A BYPASS PERFORMED. REPORTED PATIENT STATUS FOLLOWING THE SURGERY IS 'NORMAL'. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED, HOWEVER, NONE HAS BEEN PROVIDED.

    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 11036804

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R TERUMO 6F INTRODUCER SHEATH