BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS TURBO-ELITE LASER ABLATION CATHETER

    MDR report key: 3143584 · Received June 3, 2013

    Report

    Report Number
    1721279-2013-00084
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    MCW
    PMA / PMN Number
    K060012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEFT COMMON FEMORAL WAS ACCESSED WITHOUT DIFFICULTY AND PROGRESS WAS MADE TO THE RIGHT COMMON FEMORAL WHERE AN ANGIOGRAM WAS DONE. A 5F COOK SHEATH WAS INTRODUCED PRIOR TO GUIDE WIRE. THE 5F SHEATH WAS REMOVED AND A TERUMO 6F DESTINATION SHEATH WAS INTRODUCED OVER THE 0.035 TERUMO ADVANTAGE GUIDE WIRE WAS NEGOTIATED INTO THE AT ARTERY. A BURSTEIN CATHETER WAS ADVANCED OVER THE WIRE (OTW) INTO THE AT. THE WIRE WAS THEN EXCHANGED WITH A 0.14 ABBOTT BMW GUIDE WIRE AND ADVANCED TO THE ANTERIOR TIBIAL ARTERY. A 1.7MM TURBO- ELITE (TE) WAS CALIBRATED AND ADVANCED OTW TO A PROX. LESION IN THE AT. THE AREA WAS IRRIGATED WITH SALINE AND 2 PASSES WITH THE TE WERE PERFORMED AND THEN THE TE WAS RETRACTED AND CONTRAST WAS INJECTED SHOWING A SMALL PERFORATION. THE TE WAS REMOVED OTW AND AN EV 3.0 X 80MM BALLOON WAS ADVANCED OTW AND INFLATED TO 4 ATMOSPHERES FOR 3 MINUTES. TWO SUBSEQUENT INFLATIONS FOR 1 MINUTE EACH WERE DONE AFTERWARD. CONTRAST INJECTION CONFIRMED THAT THE PERFORATION WAS SEALED; HOWEVER, A SMALL ANEURYSM WAS NOTED. SUBSEQUENTLY A POPLITEAL LESION WAS TREATED WITH THE TE FOR 2 PASSES AND BALLOONED. POSTERIOR TIBIAL WAS TREATED IN A SIMILAR FASHION WITH 1 PASS FOLLOWED BY BALLOON AT 10 ATMOSPHERES WITH EXCELLENT RESULTS. TE, WIRE, SHEATH REMOVED AND PRESSURE HELD. DOPPLER SHOWED IMPROVEMENT AND PATIENT WAS DISCHARGED HOME 2 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243733 SPECTRANETICS TURBO-ELITE LASER ABLATION CATHETER TURBO ELITE MCW SPECTRANETICS CORPORTATION 417-152 FAZ13C15D

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention BURSTEIN SUPPORT CATHETER| 6F TERUMO DESTINATION SHEATH| CVX-300 EXCIMER LASER (SN 80926| 0.035 TERUMO ADVANTAGE GUIDE WIRE| 5 F COOK SHEATH| 0.14 ABBOTT BMW GUIDE WIRE| EV 3.0 X 80MM BALLOON