BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS TURBO-TANDEM LASER GUIDE CATHETER WITH LASER ATHERECTOMY CATHETER

    MDR report key: 3073689 · Received April 23, 2013

    Report

    Report Number
    1721279-2013-00049
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 2, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K112032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE VISUAL INSPECTION OF THE RETURNED DEVICE FOUND EVIDENCE THAT THE LASER SHEATH WAS ADVANCED WELL BEYOND THE CENTER OF THE ORIENTATION MARKER BAND. ALTHOUGH THE CATHETER WAS ADVANCED, IT WAS EITHER ADVANCED TOO FAR OR DURING USE THE CATHETER MOVED FORWARD (INDEPENDENT OF THE RAMP) AND BEGAN TO LASE THE TIP. THIS IS KNOWN TO OCCUR; THEREFORE, THE IFU SAYS LASING MUST BE DONE UNDER FLUORO. THE PHYSICIAN MUST ENSURE THAT THE DISTAL TIP MARKER BAND IS ALIGNED WITH THE MIDDLE OF THE BIASING RAMP MARKER BAND. WARNINGS (FROM IFU): DO NOT EXTEND THE LASER CATHETER DISTAL TIP MARKER BAND BEYOND THE ORIENTATION MARKER BAND OF THE TURBO-TANDEM SYSTEM. THIS MAY RESULT IN DAMAGE TO THE DEVICE TIP. ONLY ADVANCE AND MANIPULATE THE TURBO-TANDEM SYSTEM UNDER FLUOROSCOPIC GUIDANCE TO CONFIRM THE LOCATION AND ORIENTATION OF THE TIP. DO NOT ATTEMPT TO ADVANCE OR RETRACT THE TURBO TANDEM SYSTEM AGAINST RESISTANCE UNTIL THE REASON FOR THE RESISTANCE HAS BEEN DETERMINED BY FLUOROSCOPY OR OTHER MEANS. THIS MAY RESULT IN DEFORMATION OR DETACHMENT OF THE DISTAL TIP OR KINKING OF THE TURBO TANDEM SYSTEM. IF THE CATHETER ADVANCES BEYOND OR BEHIND THE ORIENTATION MARKER WHILE LASING AND ADVANCING THE SYSTEM, STOP AND RE-ASSESS BEFORE CONTINUING. CONTINUING TO ADVANCE THE SYSTEM OR LASE MAY RESULT IN DAMAGE TO THE TIP OF THE CATHETER.

    Description of Event or Problem · 1

    THIS WAS A VASCULAR INTERVENTION CASE TO RESOLVE A CRITICAL LIMB ISCHEMIA. THE PHYSICIAN BEGAN USING A TURBO-TANDEM. DURING THE PROCEDURE, THE LASER FELT INDEPENDENT FROM THE RAMP, AND THE LASER SHEARED OFF THE TIP OF THE TURBO-TANDEM. THE TIP TRAVELED DOWNSTREAM PAST THE POPLITEAL. THE TIP WAS RETRIEVED USING A PRONTO. PATIENT IS RECOVERING PER SURGICAL PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174625 SPECTRANETICS TURBO-TANDEM LASER GUIDE CATHETER WITH LASER ATHERECTOMY CATHETER 7F TURBO-TANDEM MCW SPECTRANETICS CORPORATION 472-110 FBX12F08D

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention CVX-300 EXCIMER LASER SN (B)(4)