BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM THRILL PTA BALLOON CATHETER

    MDR report key: 872985 · Received March 14, 2007

    Report

    Report Number
    9610978-2007-00157
    Event Type
    Malfunction
    Date Received
    March 14, 2007
    Date of Event
    February 23, 2007
    Report Date
    February 23, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO CORDIS FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY WITH LOT NUMBER. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. IN THIS CASE, FACTORS THAT CONTRIBUTED TO THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATED THAT BALLOON WAS REPORTED TO HAVE RUPTURED. THE INTENDED PROCEDURE WAS ANGIOPLASTY OF A RIGHT CEPHALIC VEIN SHUNT ANASTOMOSIS. THE VESSEL HAD UNKNOWN CALCIFICATION AND TORTUOSITY, AND A 95% STENOSIS. THE SLALOM THRILL BALLOON CATHETER WAS ADVANCED TO THE LESION AND THE BALLOON WAS INFLATED USING AN INDEFLATOR. HOWEVER, THE BALLOON RUPTURED AT 7 ATMOSPHERES. AS NOTED, VESSEL CHARACTERISTICS WERE NOT PROVIDED. IT IS UNKNOWN IF RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT OF THE CATHETER TO THE LESION OR WHILE CROSSING THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM THRILL PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R1105804

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR SHEATH INTRODUCER (UNK MFR)| RADIOFOCUS/TERUMO| GUIDEWIRE