BEUDAMED
    FDA Adverse Event Other Summary report: N

    8FR TURBO BOOSTER

    MDR report key: 1104903 · Received August 8, 2008

    Report

    Report Number
    1721279-2008-00020
    Event Type
    Other
    Date Received
    August 8, 2008
    Date of Event
    July 9, 2008
    Report Date
    August 8, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY FAILURE ANALYSIS INDICATES EXCESSIVE FORCE BEYOND DEVICE DESIGN SPECIFICATION WAS APPLIED TO HAVE PRODUCED THE PROCEDURE RESULT. FURTHER INVESTIGATION IS ON-GOING. IF FURTHER ANALYSIS RESULTS IN A DIFFERENT CONCLUSION, THEN A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CLINICAL HISTORY: THE PT WAS PRESENTING WITH LIMB ISCHEMIA. IT WAS DETERMINED THAT THERE WAS A TOTAL OCCLUSION IN A STENTED SECTION OF THE SFA. PT MET CRITERIA FOR THE SALVAGE TRIAL (PROSPECTIVE MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND PERFORMANCE OF THE SPECTRANETICS LASER WITH ADJUNCT PTA AND GORE ENDOPROSTHESIS FOR THE TREATMENT OF IN-STENT RESTENOSIS) AND WAS SUBSEQUENTLY ENROLLED. PROCEDURE: AN 8FR TURBO BOOSTER WAS USED WITH A 2.0 TURBO ELITE TO CREATE A LUMEN THROUGH THE OCCLUSION. THE PT HAD A FRACTURED STENT. SO WHEN ATTEMPTING TO REMOVE THE DEVICE, THE FRACTURED STRUTS ON THE STENT CAUGHT THE DISTAL END OF THE TURBO BOOSTER THAT CONTAINS AN ENCAPSULATED RADIOPAQUE MARKER. THE DISTAL TIP WAS PULLED WITH SUFFICIENT FORCE TO CAUSE THE DISTAL END TO DETACH FROM THE CATHETER. THE TIP TRAVELED THROUGH THE SFA AND STOPPED IN THE PERONEAL ARTERY. THE DOCTOR WAS ABLE TO TRAP THE TIP AGAINST THE ARTERY WALL BY USING A MINI-VISION STENT THEREBY REDUCING THE POTENTIAL FOR PT INJURY. PT OUTCOME: AFTER THE PROCEDURE, AN ANGIO SHOWED GOOD FLOW. PT HAD NO RESIDUAL EFFECT AND IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8FR TURBO BOOSTER TB LASER GUIDE CATHETER LPC SPECTRANETICS CORP. 518-063 0707092

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SPECTRANETICS CVX-300 LASER