BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTERA PRO 2.5/30

    MDR report key: 6260850 · Received January 18, 2017

    Report

    Report Number
    1028232-2017-00082
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    December 28, 2016
    Report Date
    January 9, 2017
    Manufacturer
    BIOTRONIK AG
    Product Code
    LOX
    PMA / PMN Number
    K160985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING HISTORY OF THE PRODUCTION LOT DID NOT REVEAL ANY NONCONFORMITY. THE COMPLAINT INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND SUCCESSFULLY PASSED ALL IN-PROCESS INSPECTIONS AS WELL AS THE FINAL INSPECTION. THE TECHNICAL INVESTIGATION OF THE COMPLAINT INSTRUMENT REVEALED THAT THE DEVICE IS KINKED AND THE INFLATION LUMEN IS SLICED OPEN AT THE GUIDE WIRE EXIT PORT, MAKING IT IMPOSSIBLE TO ASSESS THE INFLATION/DEFLATION BEHAVIOR. IT WAS RETURNED NOT WELL DEFLATED AND WITH DRIED CONTRAST MEDIUM RESIDUE INSIDE THE BALLOON. THE OUTER SHAFT HAS BEEN DEFORMED AND HAS NARROWED DOWN AT THE PROXIMAL BALLOON WELD CAUSING A BLOCKAGE OF THE INFLATION LUMEN. SIMULATIONS HAVE CONFIRMED THAT THIS TYPE OF DEFORMATION CAN BE CAUSED BY A TENSILE FORCE APPLIED TO THE INSTRUMENT. THE DEFORMATION MUST HAVE OCCURRED DURING THE PROCEDURE, E. G. BY PULLING THE NOT COMPLETELY DEFLATED BALLOON BACK AGAINST THE GUIDING CATHETER, OR DURING ITS PREPARATIONS FOR THE PROCEDURE. NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE WAS DETERMINED.

    Additional Manufacturer Narrative · 1

    ON 3/29/2017. THE DEVICE WAS RETURNED FOR EVALUATION. THE EVALUATION IS STILL IN PROCESS. METHOD CODES AND A CONCLUSION CODE WAS PROVIDED.

    Description of Event or Problem · 1

    THE PANTERA PRO BALLOON COULD NOT BE DEFLATED (WITHDRAWN) INTO THE GUIDING CATHETER (UNKNOWN SIZE).

    Description of Event or Problem · 1

    OUS MDR. THE PANTERA PRO BALLOON COULD NOT BE DEFLATED (WITHDRAWN) INTO THE GUIDING CATHETER (UNKNOWN SIZE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42445 PANTERA PRO 2.5/30 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER LOX BIOTRONIK AG 393318 10160734

    Patients

    Seq Age Sex Outcome Treatment
    1