BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 919635 · Received September 25, 2007

    Report

    Report Number
    9610978-2007-00364
    Event Type
    Malfunction
    Date Received
    September 25, 2007
    Date of Event
    August 30, 2007
    Report Date
    August 30, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    K012590
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE PULLING NEGATIVE PRESSURE DURING PREP FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AIR WAS NOTICED IN THE SYRINGE OF THE PRODUCT. UPON EXAMINATION OF THE BALLOON, A HOLE WAS NOTICED. THERE WAS NO REPORTED PATIENT INJURY. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY E7136292 WITH LOT NUMBER 0511060273 AND TO SUBASSEMBLY E7145365 WITH LOT NUMBER 0110061186. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES.

    Description of Event or Problem · 1

    WHILE PULLING NEGATIVE PRESSURE DURING PREP, AIR WAS NOTICED IN THE SYRINGE OF THE PRODUCT. A HOLE WAS NOTICED IN THE BALLOON OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R1106378

    Patients

    Seq Age Sex Outcome Treatment
    1 YR