BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 1061013 · Received June 12, 2008

    Report

    Report Number
    9610978-2008-00148
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON WAS INFLATED SUCCESSFULLY IN THE PROXIMAL PART OF THE LESION. SUBSEQUENTLY, THE BALLOON WAS DEFLATED AND INFLATED A SECOND TIME IN A HIGHLY CALCIFIED SEGMENT, HOWEVER, BALLOON RUPTURED AT 6 ATMOSPHERES. ATTEMPTS TO ASPIRATE THE BALLOON WERE MADE. PROXIMAL PART OF THE BALLOON DEFLATED IN THE USUAL SHORT TIME, HOWEVER, THE BALLOON PART DISTALLY FROM THE RUPTURE DEFLATED VERY SLOWLY, APPROX 2 MINUTES. IN ADDITION, IT WAS DIFFICULT TO RETRIEVE THE BALLOON THROUGH THE SHEATH INTRODUCER (SI) AND SYSTEM WAS REMOVED WITH FORCE. THERE WERE NO ISSUES WITH THE SI. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PT WITHOUT ADVERSE CONSEQUENCES. OUTSIDE THE PT, THE PHYSICIAN RECOGNIZED AND NOTED THAT THERE WAS ONLY PINHOLE IN THE BALLOON, AND NOT A LONGITUDINAL RUPTURE. THEREFORE, THE CONTRAST COULD NOT BE ASPIRATED VERY WELL. THE INTERVENTION WAS COMPLETED WITH ANOTHER BALLOON SUCCESSFULLY. THIS PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT DURING A BALLOON ANGIOPLASTY TO THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), THE BALLOON RUPTURE. SUBSEQUENTLY, THERE WAS DEFLATION DIFFICULTY AND THE SYSTEM WAS RETRIEVED WITH FORCE. THE DEVICE APPEARED PERFECT DURING PRE-USE PRODUCT INSPECTION, AND WAS PREPPED FOLLOWING THE INSTRUCTION FOR USE (IFU). THE GUIDEWIRE LUMEN WAS FLUSHED AND NO ANOMALIES WERE NOTED DURING DEVICE PREPARATION. THE BALLOON WAS PREPPED WITH THE INDEFLATOR USING ACCUPAK (GE) CONTRAST MEDIUM WITH A 50:50 CONCENTRATION OF CONTRAST TO HEPARINIZED SALINE. APPROACH WAS MADE FROM LEFT GROIN TO A HIGHLY CALCIFIED TYPE C LESION. THE LESION MEASURED 8 CM IN LENGTH AND HAD A REFERENCE VESSEL DIAMETER OF 6MM. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL NOR WHEN CROSSING THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0606364

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR V-18 GUIDEWIRE/BOSTON SCI| 4F-11CM TERUMO SHEATH INTRODUCER (SI)| QL INFLATION DEVICE/ATRION MEDICAL