BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 1041273 · Received May 9, 2008

    Report

    Report Number
    9610978-2008-00123
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY WITH LOT NUMBERS 0202080101 AND 0201080233. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. THIS PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT COMPLETE. ADDITIONAL INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED A HOLE WAS FOUND IN THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WHEN ATTEMPTS WERE MADE TO FLUSH THE DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT. NO ADDITIONAL INFO HAS BEEN PROVIDED IN RESPONSE TO REQUEST FOR PT, VESSEL CHARACTERISTICS AND PROCEDURAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0208206

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK