BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.7 TURBO ELITE AND 7FR. TURBO BOOSTER

    MDR report key: 1034803 · Received April 23, 2008

    Report

    Report Number
    1721279-2008-00006
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 21, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MISSING CATHETER TIP WAS NOT RETURNED WITH THE CATHETER, MAKING IT DIFFICULT TO DETERMINE IF THERE MAY HAVE BEEN A PROBLEM WITH THE TIP BONDING PROCESS OR IF EXCESSIVE FORCE MAY HAVE BEEN USED WHILE REMOVING THE CATHETER. ALTHOUGH THIS IS THE FIRST REPORT OF A TIP COMING OFF OF A TURBO ELITE CATHETER DURING THE PROCEDURE, FURTHER ENGINEERING INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE PHYSICIANS SUCCESSFULLY CREATED AN INITIAL CHANNEL IN THE SFA/POPLITEAL USING A .9 TURBO ELITE CATHETER. TOTAL LASER TREATMENT TIME: 3:01 AND TOTAL PULSES DELIVERED 4962. THE PHYSICIANS UPSIZED THE CATHETER TO 1.7 MM AND TOOK AN INITIAL PASS AT 60/40. THEY FELT RESISTANCE DUE TO SOME MODERATE CALCIUM AND TOOK THE SETTINGS UP TO 60/60 ADVANCING THE CATHETER SLOWLY (APPROX 1MM PER SECOND) UNTIL ALL OF A SUDDEN THE CATHETER "JUMPED" FORWARD. AT THAT TIME, IT APPEARED THAT THE CATHETER WOULD NOT ADVANCE OR RETRACT. THE PHYSICIANS WERE SUCCESSFUL IN REMOVING THE CATHETER BUT THE TIP (.067" OD X .085" LG) WAS LEFT IN THE SFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.7 TURBO ELITE AND 7FR. TURBO BOOSTER TURBO ELITE LASER CATHETER GEX SPECTRANETICS CORP. 417-152 071212B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention