BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSEO-18

    MDR report key: 1211777 · Received October 24, 2008

    Report

    Report Number
    1028232-2008-01277
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    June 12, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LIT
    PMA / PMN Number
    K072765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DETAILED TECHNICAL ANALYSIS OF THE RETURNED INSTRUMENT REVEALED A CIRCUMFERENTIAL RUPTURE IN THE MIDDLE OF THE BALLOON, WHICH DIVIDED IT INTO TWO PARTS. THE DISTAL PART WAS FOUND COMPRESSED TO THE DISTAL WELD AND THE INNER SHAFT WAS BROKEN AT THE INNER SHAFT BOND. THE INVESTIGATION OF THE BALLOON SURFACE UNDER 50X MAGNIFICATION REVEALED SEVERAL ABRASIVE NARROW GROOVES VERY CLOSE TO THE FRACTURED AREA. BASED ON OUR FINDINGS, WE CONCLUDED THAT THE PRODUCT WAS NOT THE ROOT CAUSE FOR THE REPORTED CASE. OUT OF THE ANALYSIS RESULTS AND THE PROVIDED INFO, WE ASSUME THAT THE BALLOON SURFACE WAS PENETRATED BY THE CALCIFIED LESION DURING THE INFLATION OF THE BALLOON. ADDITIONAL INFORMATION: THE NUMBER IN SECTION D4 (SERIAL NUMBER) IS A REFERENCE NUMBER. THERE ARE NO SERIAL NUMBERS FOR CATHETERS. (SEE SCANNED PAGE).

    Description of Event or Problem · 1

    OUS MDR, AN ANGIOPLASTY OF A CALCIFIED AND TORTUOUS RADIAL ARTERY, WHICH HAD A DIAMETER OF 5MM, A LESION LENGTH OF 10MM AND A STENOSIS DEGREE OF 75% WAS PERFORMED FOR VASCULAR ACCESS. DURING INFLATION, THE BALLOON RUPTURED AT A PRESSURE OF 14 BAR. IT WAS REPORTED THAT IT WAS DIFFICULT TO WITHDRAW THE BALLOON. THEREFORE, THE PHYSICIAN NEEDED A LOT OF FORCE TO REMOVE THE BALLOON. AFTER WITHDRAWING, IT WAS NOTED THAT THE DISTAL PART OF THE CATHETER STAYED IN THE PATIENT. THE PRESENCE OF THE TWO RADIOPAQUE MARKERS WAS NOTED ON THE ROADMAPPING. SINCE THE DISTAL PART OF THE BALLOON CATHETER COULD NOT BE WITHDRAWN, IT WAS NECESSARY TO PERFORM A SURGICAL OPENING OF THE VEIN FOR REMOVAL OF THE REMAINING BALLOON AND REALIZATION OF PERIPHERAL BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSEO-18 CATHETER, ANGIOPLASTY, BALLOON DILATION LIT BIOTRONIK GMBH AND CO. 357466

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization