BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM THRILL PTA BALLOON CATHETER

    MDR report key: 822805 · Received January 25, 2007

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    Report

    Report Number
    9610978-2007-00059
    Event Type
    Malfunction
    Date Received
    January 25, 2007
    Date of Event
    December 28, 2006
    Report Date
    December 29, 2006
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE SLALOM THRILL PTA CATHETER IS SIMILAR TO THE SLALOM PTA CATHETER. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS (R0406428) MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7144631 WITH LOT NUMBER 0304060223. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE BURST TEST VALUES. WITH THE LIMITED AMOUNT OF INFO AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE, IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORT EVENT.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO THE LEFT SHUNT ANASTOMOSIS, THE BALLOON WAS REPORTED TO HAVE RUPTURED. THE VESSEL HAD SEVERE CALCIFICATION, SEVERE TORTUOSITY AND A 90% STENOSIS. A GUIDEWIRE WAS INSERTED ACROSS THE LESION VIA SHEATH INTRODUCER. THE BALLOON CATHETER WAS ADVANCED TO THE LESION OVER THE GUIDEWIRE THROUGH THE SHEATH INTRODUCER AND THE BALLOON WAS INFLATED USING AN INDEFLATOR. HOWEVER, THE BALLOON RUPTURED AT BELOW NOMINAL PRESSURE DURING THE FIRST INFLATION. THE BALLOON CATHETER WAS WITHDRAWN FROM THE PT'S BODY AND ANOTHER BALLOON CATHETER WAS USED TO END PROCEDURE SUCCESSFULLY. THE PRODUCT WAS PREPARED AND USED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM THRILL PTA BALLOON CATHETER PTA CATHETER (LIT) LTI CORDIS EUROPA, N.V. NA R0406428

    Patients

    Seq Age Sex Outcome Treatment
    1 * SLALOM THRILL/CORDIS (439-6020T)| 6F SHEATH INTRODUCER/MEDIKIT| 0.016 INCH/TERUMO| GT WIRE| INDEFLATOR ENCORE/BOSTON