BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM PTA DILATATION CATHETER

    MDR report key: 923471 · Received March 29, 2007

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    Report

    Report Number
    9610978-2007-00195
    Event Type
    Malfunction
    Date Received
    March 29, 2007
    Date of Event
    March 21, 2007
    Report Date
    March 21, 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 DEVICE WAS NOT RETURNED TO CORDIS FOR ANALYSIS. A DHR REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MQP. THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7144621 WITH LOT NUMBER 0411066472. THIS REVIEW REVEALED THAT THE SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. WITHOUT RETURN OF THE PRODUCT, IT CANNOT BE CONFIRMED IF THE OUTER SURFACE OF THE BALLOON MATERIAL REVEALED EVIDENCE OF SURFACE ABRASIONS THAT MIGHT HAVE CAUSED THE BALLOON BURST. WITH THE INFORMATION AVAILABLE, FACTORS THAT CONTRIBUTED TO THE REPORTED BALLOON BURST CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED. THE INTENDED PROCEDURE WAS ANGIOPLASTY OF A SHUNT ANASTOMOSIS. PER REPORT, THE VESSEL WAS NEITHER CALCIFIED NOR TORTUOUS, THE RATE OF STENOSIS IS UNK. THE SLALOM THRILL BALLOON CATHETER WAS USED TO DILATE THE LESION. DURING THE FOURTH INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. AN INDEFLATOR WAS USED. NO ADDITIONAL PATIENT, LESION/VESSEL OR PROCEDURAL DETAILS WERE PROVIDED. IT IS UNK IF ANY DIFFICULTY WAS EXPERIENCED WHILE ADVANCING THE BALLOON CATHETER TO THE LESION OR WHILE CROSSING THE LESION. IT IS UNKNOWN IF THE BALLOON WAS INFLATED ABOVE RATED BURST PRESSURE ON ANY OR ALL OF THE PRIOR THREE INFLATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM PTA DILATATION CATHETER PTA CATHETERS LIT CORDIS EUROPA, N.V. NA R1206294

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR