BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM THRILL PTA BALLOON CATHETER

    MDR report key: 807389 · Received December 12, 2006

    Report

    Report Number
    9610978-2007-00023
    Event Type
    Malfunction
    Date Received
    December 12, 2006
    Date of Event
    December 12, 2006
    Report Date
    December 12, 2006
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS (R0706278) MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER 10402838 WITH LOT NUMBER 0107060081. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE BURST TEST VALUES. IN THIS CASE, THERE IS NOT ENOUGH INFO TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT THE BALLOON WOULD NOT INFLATE. THE INTENDED PROCEDURE WAS ANGIOPLASTY OF A SHUNT ANASTOMOSIS. LESION CHARACTERISTICS WERE NOT PROVIDED. THE TARGET LESION WAS WIRED WITHOUT DIFFICULTY. THE SLALOM THRILL BALLOON CATHETER WAS PREPPED AND CLINICALLY USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS ADVANCED TO THE LESION AND POSITIONED. USING AN INDEFLATOR AND ATTEMPT TO INFLATE THE BALLOON WAS MADE, HOWEVER, THE BALLOON DID NOT INFLATE. THE DEVICE WAS REMOVED AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON OUTSIDE THE PT. AT THIS TIME, A LEAKAGE IN THE BALLOON WAS NOTED.

    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 R0706278

    Patients

    Seq Age Sex Outcome Treatment
    1 YR GUIDEWIRE| SHEATH INTRODUCER