BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTERA PRO 2.5/20

    MDR report key: 8302716 · Received February 4, 2019

    Report

    Report Number
    1028232-2019-00349
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    July 10, 2018
    Report Date
    February 4, 2019
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LOX
    PMA / PMN Number
    K160985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED INSTRUMENT WAS SUBJECTED TO A TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. THE TECHNICAL INVESTIGATION OF THE RETURNED PANTERA PRO REVEALED THAT THE BALLOON HAS BEEN IN- AND DEFLATED. HOWEVER, DURING ANALYSIS PRESSURE COULD BE APPLIED UP TO RBP BUT THE MEASURED IN- AND DEFLATION TIME WAS IMPEDED. FURTHER INVESTIGATION REVEALED A NARROWED AREA CLOSE TO THE PROXIMAL BALLOON NECK, MOST CERTAINLY CAUSED BY A TENSILE FORCE APPLIED TO THE DEVICE DURING THE APPLICATION. THE DEFORMATION MUST HAVE OCCURRED DURING PROCEDURE, E. G. BY PULLING THE NOT COMPLETELY DEFLATED BALLOON BACK AGAINST THE GUIDING CATHETER. THE SCREENING OF THE MANUFACTURING HISTORY SHOWED THAT THE DEVICE IN QUESTION WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS AND SUCCESSFULLY PASSED ALL IN-PROCESS CONTROLS AS WELL AS THE FINAL INSPECTION. DURING FINAL INSPECTION EVERY INSTRUMENT IS VISUALLY INSPECTED. FURTHERMORE ALL DEVICES ARE SHIPPED WITH A 0.015 INCH TRANSPORTATION WIRE INSIDE THE GUIDE WIRE LUMEN. WE CAN THEREFORE CONFIRM THAT THE DEVICE WAS IN ACCORDANCE WITH THE SPECIFICATIONS AT THE TIME OF DELIVERY. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    OUS MDR - BALLOON COULD NOT BE DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96360 PANTERA PRO 2.5/20 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER LOX BIOTRONIK AG, BUELACH, SWITZERLAND 393308 05180099

    Patients

    Seq Age Sex Outcome Treatment
    1