BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-14 2.5/100/150

    MDR report key: 7059685 · Received November 27, 2017

    Report

    Report Number
    1028232-2017-04268
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 16, 2017
    Manufacturer
    BIOTRONIK AG
    Product Code
    LIT
    PMA / PMN Number
    K152240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED INSTRUMENT WAS SUBJECTED TO A DETAILED TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THIS EVENT. THE TECHNICAL INVESTIGATION OF THE RETURNED PAASSEO-14 REVEALED THAT THE BALLOON HAS BEEN INFLATED. IT WAS RETURNED IN A FULLY DEFLATED STATE WITH BLOOD RESIDUE INSIDE THE BALLOON LUMEN. AT A PRESSURE OF 4-5 ATM SEVERAL JETS OF WATER WERE OBSERVED NEAR THE CENTER OF THE BALLOON. FURTHER MICROSCOPIC ANALYSIS SHOWED TWO SCRATCHES ON THE BALLOON SURFACE DIRECTLY AT AND NEARBY THE LEAKAGE SITE. THE REVIEW OF THE PRODUCTION DOCUMENTATION OF 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. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MANUFACTURING OR MATERIAL RELATED ROOT CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    DURING INFLATION THE PASSEO-14 BURST AT 8 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840324 PASSEO-14 2.5/100/150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETE LIT BIOTRONIK AG 380333 07162135

    Patients

    Seq Age Sex Outcome Treatment
    1