BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTERA LEO 3.0/12

    MDR report key: 8540414 · Received April 23, 2019

    Report

    Report Number
    1028232-2019-01566
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    LOX
    UDI-DI
    07640130415645
    PMA / PMN Number
    K163660
    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 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 PANTERA LEO REVEALED THAT THE BALLOON HAS BEEN INFLATED. MICROSCOPIC ANALYSIS SHOWED A PINHOLE ABOUT 1 MM DISTAL TO THE DISTAL XRAY MARKER AND SCRATCHES ON THE BALLOON SURFACE NEARBY THE DAMAGE 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 INPROCESS 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. THE ROOT CAUSE IS MOST LIKELY RELATED TO THE PATIENTS ANATOMY.

    Description of Event or Problem · 1

    OUS MDR - THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION. DURING INFLATION THE BALLOON RUPTURED AT 14 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334293 PANTERA LEO 3.0/12 BASIC CORONARY ANGIOPLASTY BALLOON CATHETER LOX BIOTRONIK AG, BUELACH, SWITZERLAND 367006 11186584 07640130415645

    Patients

    Seq Age Sex Outcome Treatment
    1