BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACIFIC XTREME PTA BALLOON CATHETER

    MDR report key: 2243900 · Received August 24, 2011

    Report

    Report Number
    3004066202-2011-00034
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    July 28, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES, SPA.
    Product Code
    LIT
    PMA / PMN Number
    K103464
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: BASED ON THE LIMITED INFO PROVIDED AND NON-DEVICE RETURN NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT WHILE ATTEMPTING TO USE THE PACIFIC XTREME PTA BALLOON CATHETER DIAMETER 5MM LENGTH 60MM, DEFLATION WAS SLOWER THAN IN THE PAST. BAD REFOLDING WAS ALSO REPORTED TO HAVE PREVENTED RE-USE OF THE CATHETER IN THE SAME LESION. IT IS REPORTED THAT THE EVENT DID NOT AFFECT THE PT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACIFIC XTREME PTA BALLOON CATHETER LIT INVATEC INNOVATIVE TECHNOLOGIES, SPA. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK