BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-KINETIC ENERGY 5.0/15

    MDR report key: 6463735 · Received April 6, 2017

    Report

    Report Number
    1028232-2017-01179
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    March 22, 2017
    Report Date
    April 5, 2017
    Manufacturer
    BIOTRONIK AG
    Product Code
    MAF
    PMA / PMN Number
    P160003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON WAS STILL FOLDED AND SHOWED NO SIGNS OF INFLATION AT THE TIME THE DEVICE WAS RETURNED FOR INVESTIGATION. MICROSCOPIC INVESTIGATION OF THE GEP REVEALED THAT THE GUIDE WIRE LUMEN AND THE INFLATION LUMEN ARE SLICED OPEN. THEREFORE, THE STENT COULD NOT BE INFLATED. THE DESCRIBED OBSERVATION WAS MOST PROBABLY INDUCED BY THE GUIDE WIRE DURING THE PROCEDURE. THE LEAKAGE OF THE INFLATION LUMEN IS PRESUMABLY A DIRECT CONSEQUENCE OF THE GUIDE WIRE EXIT PORT LYING OUTSIDE OF THE GUIDING CATHETER WHICH IS WARNED AGAINST IN THE IFU. FURTHER THE DEVICE WAS USED AGAINST THE INDICATION OUTLINED IN THE IFU. A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE PRODUCT DETAILED ABOVE VERIFIED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN PROCESS AND FINAL INSPECTION. IN ADDITION TO VISUAL INSPECTIONS EACH INSTRUMENT IS TESTED FOR AIR TIGHTNESS BY MEANS OF A HELIUM LEAK TEST. WE CAN THEREFORE CONFIRM THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATION AND DELIVERED IN A LEAK PROOF CONDITION. 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

    THE PKE STENT BALLOON DID NOT INFLATE. PKE STENT SYSTEM WAS REMOVED AND ANOTHER PKE STENT SYSTEM WAS USED TO SUCCESSFULLY CLOSE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251317 PRO-KINETIC ENERGY 5.0/15 BARE-METAL CORONARY ARTERY STENT MAF BIOTRONIK AG 371460 11155851

    Patients

    Seq Age Sex Outcome Treatment
    1