BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1040077 · Received May 7, 2008

    Report

    Report Number
    3004742232-2008-00002
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 7, 2008
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED THAT THERE WERE NO DEFECTS OR ABNORMALITIES IN THE CROWN AREA OR THE TIP BUSHING AREA OF THE OAD. THE OAD HANDLE'S BACK TELESCOPE HYPOTUBE (DISTAL END LEADING INTO THE TURBINE HOUSING) WAS FLARED AND THE INNER DIAMETER OF THE TUBE WAS WORN. THESE FINDINGS INDICATE THAT THE DRIVE SHAFT BECAME BUCKLED OR MISALIGNED DURING USE. THE GUIDE WIRE WAS FRACTURED IN TWO LOCATIONS. THE DISTAL FRACTURE WAS LOCATED NEAR THE PROXIMAL END OF THE SPRING TIP. THE OTHER FRACTURE OCCURRED PROXIMALLY AT THE TURBINE ASSEMBLY. BOTH GUIDE WIRE FRACTURES AND THE DRIVE SHAFT FRACTURE APPEARED TO HAVE FAILED IN TORSION. IT APPEARS THAT THE DRIVE SHAFT AND GUIDE WIRE BECAME LOCKED TOGETHER DURING OPERATION OF THE OAD DUE TO THE PRODUCTION OF HEAT GENERATED BY AN UNK SOURCE. THE GUIDE WIRE BRAKE RESISTED THE ROTATION OF THE GUIDE WIRE, WHICH CAUSED A TORSIONAL FAILURE IN BOTH THE DRIVE SHAFT AND THE GUIDE WIRE. THE HIGH STRESS AND STRAIN RATES EXPERIENCED BY THE DEVICE DURING RAPID DECELERATION FROM OPERATING SPEEDS CAUSED THE GUIDE WIRE AND THE DRIVE SHAFT TO FRACTURE. THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT IS UNK, PREVIOUS INVESTIGATIONS HAVE REVEALED THAT HEAT PRODUCTION CAUSING FUSION OF THE DRIVE SHAFT TO THE GUIDE WIRE CAN BE CAUSED BY A KINK IN THE GUIDE WIRE. A KINKED GUIDE WIRE CAN RUB ON THE DRIVE SHAFT CAUSING FRICTION. THE HEAT GENERATED BY THE FRICTION MAY CAUSE THE DRIVE SHAFT TO BOND TO THE GUIDE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY TREATMENT PROCEDURE, THE VIPERWIRE FRACTURED AND LODGED IN A COLLATERAL VESSEL IN THE PT'S ANKLE AND REMAINS IN THE PT'S BODY. THE LESION BEING TREATED WAS 6 MM LONG, 95% STENOTIC, HEAVILY CALCIFIED. IT WAS LOCATED IN THE TIBIAL - PERONEAL TRUNK (TPT) WHICH RANGED IN SIZE FROM 3.5 TO 2 MM. THE PHYSICIAN INITIATED TREATMENT WITH A 1.25, 70-GRIT CROWN ON A FIRM VIPERWIRE. HE SPUN FOR 5 MINUTES, 50 SECONDS OVER AN 18 TO 20CM AREA AND HAD VERY GOOD RESULTS. THE PHYSICIAN DECIDED TO UPSIZE TO A 1.75, 70-GRIT CROWN TO REMOVE ADD'L CALCIUM FROM THE PROXIMAL TPT. HE LOADED THE DEVICE ON THE WIRE AND TESTED IT, WITH NORMAL PERFORMANCE. AFTER MOVING THE DEVICE PROXIMAL TO THE FIRST LESION. THE PHYSICIAN TRADED PLACES WITH THE FELLOW AND PLACED THE CONTROLLER ON HIGH TO START THE FIRST RUN. ONCE HE STARTED SPINNING, A STRANGE SOUND WAS AUDIBLE, AND 4 SECONDS INTO THE RUN THE FELLOW SAID HE WAS HAVING TROUBLE MOVING THE THROW. HE SHUT THE DEVICE DOWN AT 9 SECONDS AND NOTED THAT A WIRE WAS VISIBLE IN THE DEVICE HANDLE. HE MOVED THE FLUORO DOWN AND SAW THAT THE WIRE WAS FRACTURED AND THE TIP REMAINED NEAR THE PT'S ANKLE. THE DEVICE WAS REMOVED WITH THE CROWN IN PLACE. THE PHYSICIAN WORKED WITH SNARES AND A COMBINATION OF CATHETERS TO RETRIEVE THE TIP OF THE WIRE, BUT WAS UNSUCCESSFUL. THE TIP OF THE VIPERWIRE REMAINED IN A COLLATERAL VESSEL FROM THE PERONEAL ARTERY AT THE PT'S ANKLE. THE FINAL PICTURES SHOWED GOOD BLOOD FLOW IN AND AROUND THE PERONEAL, THE COLLATERALS TO THE POSTERIOR TIBIAL AND THE ANTERIOR TIBIAL, AND GOOD FLOW IN THE ARCH OF THE FOOT. THE PT HAD NO PAIN OR COMPLAINTS. AFTER A CONSULT WITH A VASCULAR SURGEON, THE PHYSICIAN ELECTED TO LEAVE THE WIRE IN PLACE RATHER THAN TAKE SURGICAL ACTION IN ORDER TO AVOID A POSSIBLE NON-HEALING WOUND POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS, INC. DB-70-175L 13395

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R