BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-KINETIC ENERGY 3.0/9

    MDR report key: 6810551 · Received August 22, 2017

    Report

    Report Number
    1028232-2017-02836
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    July 19, 2017
    Report Date
    August 10, 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 AFFECTED PRO-KINETIC ENERGY (PKE) DELIVERY SYSTEM, INCLUDING THE STILL CRIMPED STENT, WAS RETURNED ON THE USED GUIDE WIRE. THE INSPECTION REVEALED THAT THE AFFECTED PKE HAS BEEN TORQUED. DURING THE FURTHER INVESTIGATION, THE USED GUIDE WIRE WAS REMOVED FROM THE PKE. IT WAS DETECTED THAT THE USED GUIDE WIRE AND THE DISTAL SHAFT OF THE AFFECTED PKE WERE PERMANENTLY DEFORMED. A PKE REFERENCE INSTRUMENT COULD BE MOVED ON THE USED GUIDE WIRE WITH LITTLE FRICTION. IN A NEXT STEP A REFERENCE GUIDE WIRE (0.35 MM) WAS INSERTED INTO THE PKE WITHOUT UNUSUAL FRICTION WHEREAS A TRANSPORTATION WIRE (0.39 MM) COULD ONLY BE INSERTED UP TO THE DEFORMED PART OF THE DISTAL SHAFT BEFORE HIGH FRICTION WAS FELT. THE REVIEW OF THE MANUFACTURING HISTORY OF THE PRODUCTION LOT DID NOT REVEAL ANY NONCONFORMITY. THE AFFECTED PKE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND SUCCESSFULLY PASSED ALL IN-PROCESS INSPECTIONS AS WELL AS THE FINAL INSPECTION. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICES BEING SUBJECT TO THIS COMPLAINT, NO MANUFACTURING OR MATERIAL RELATED ROOT CAUSE COULD BE IDENTIFIED. IT APPEARS THAT THE GUIDE WIRE LUMEN OF THE AFFECTED PKE WAS DEFORMED EITHER AS A RESULT OF THE APPLIED TORSIONAL LOAD.

    Description of Event or Problem · 1

    AFTER PRE-DILATATION THE PRO-KINETIC ENERGY COULD NOT PASS THE MODERATE CALCIFIED LESION AND GOT STUCK ON THE WIRE. THE STENT SYSTEM WAS REMOVED TOGETHER WITH THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591633 PRO-KINETIC ENERGY 3.0/9 STENT, CORONARY MAF BIOTRONIK AG 360494 10163877

    Patients

    Seq Age Sex Outcome Treatment
    1