BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM THRILL PTA BALLOON CATHETER

    MDR report key: 853538 · Received March 2, 2007

    Report

    Report Number
    9610978-2007-00123
    Event Type
    Malfunction
    Date Received
    March 2, 2007
    Date of Event
    February 5, 2007
    Report Date
    February 5, 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 (R0705063) MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7144621 WITH LOT NUMBER 0207050136. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE BURST TEST VALUES. IN THIS CASE, LESION/VESSEL CHARACTERISTICS LIKELY CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT THE BALLOON USED DURING PROCEDURE RUPTURED. THE INTENDED PROCEDURE WAS ANGIOPLASTY OF A SHUNT ANASTOMOSIS. THE VESSEL HAD MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE PRODUCT WAS POSITIONED AT THE TARGET LESION AND THE BALLOON WAS INFLATED USING AN INDEFLATOR, HOWEVER, THE BALLOON RUPTURED AT 6 ATMOSPHERES. IT IS UNK IF ANY RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE BALLOON CATHETER TO THE LESION OR WHILE CROSSING THE LESION. NO ADD'L PT, LESION/VESSEL OR PROCEDURAL DETAILS WERE PROVIDED.

    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 R0705063

    Patients

    Seq Age Sex Outcome Treatment
    1 YR