BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-35 6/120/130

    MDR report key: 11860318 · Received May 20, 2021

    Report

    Report Number
    1028232-2021-02754
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LIT
    UDI-DI
    07640130434615
    PMA / PMN Number
    K082933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT 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. AS PART OF THE TECHNICAL INVESTIGATION FUNCTIONAL TESTING WAS PERFORMED. DURING INFLATION THE BALLOON OPENED, BUT THE PRESSURE COULD NOT BE HELD DUE TO A FINE JET WATER EMERGING FROM THE PROXIMAL PART OF THE BALLOON. MICROSCOPIC ANALYSIS OF THE BALLOON SURFACE REVEALED A SMALL PINHOLE WITH TRANSVERSAL ORIENTATION ABOUT 29 MM DISTAL TO THE PROXIMAL X-RAY MARKER. A LONG DEEP SCRATCH AND SEVERAL SMALL SCRATCHES WERE OBSERVED IN CLOSE VICINITY TO THE PINHOLE. IT THEREFORE SEEMS LIKELY THAT THE DAMAGE OF THE BALLOON SURFACE WAS CAUSED BY A HARD, SHARP-EDGED OBJECT PRESSING AGAINST THE BALLOON FROM THE OUTSIDE. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. IN ADDITION TO VISUAL INSPECTIONS EACH INSTRUMENT IS TESTED FOR AIR TIGHTNESS BY MEANS OF A HELIUM LEAK TEST AND A PRESSURE TEST. WE CAN THEREFORE CONFIRM THAT THE INSTRUMENT WAS DELIVERED IN A LEAK-PROOF CONDITION. BASED ON THE CONDUCTED INVESTIGATIONS, NO MANUFACTURING OR MATERIAL RELATED ROOT CAUSE COULD BE DETERMINED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT EVENT IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY (I.E. SEVERE CALCIFICATION).

    Description of Event or Problem · 1

    THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS SFA. THE BALLOON WAS INFLATED AT 4 BAR AND THE PRESSURE COULD NOT BE INCREASED ANYMORE. DURING THE ATTEMPT TO DEFLATE AND INFLATE THE BALLOON AGAIN, BLOOD APPEARED IN THE SYRINGE OF THE INFLATION DEVICE. THE BALLOON WAS CONFIRMED BURST WHEN IT WAS TAKEN OUT AND FLUSH WITH SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750813 PASSEO-35 6/120/130 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BIOTRONIK AG, BUELACH, SWITZERLAND 383279 05186631 07640130434615

    Patients

    Seq Age Sex Outcome Treatment
    1