BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2935277 · Received January 30, 2013

    Report

    Report Number
    3004742232-2013-00004
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OAD WAS RECEIVED WITH THE ORIGINAL GUIDE WIRE ENGAGED IN THE DEVICE. THE INITIAL VISUAL AND TACTILE EXAMINATION OF THE HANDLE ASSEMBLY, SALINE SHEATH AND DRIVESHAFT DID NOT REVEAL ANY DAMAGE OR ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT; THE CROWN AND DISTAL TIP BUSHING REMAINED INTACT AND UNDAMAGED. NO BIOLOGICAL MATERIAL WAS OBSERVED ON THE DRIVESHAFT OR CROWN. THE GUIDE WIRE WAS REMOVED PROXIMALLY FROM THE OAD WITH SIGNIFICANT RESISTANCE. VISUAL AND TACTILE EXAMINATION OF THE GUIDE WIRE REVEALED SEVERAL BENDS LOCATED WITHIN THE HANDLE ASSEMBLY. THIS DAMAGE APPEARS TO BE THE RESULT OF HANDLING OR MANIPULATING THE DEVICE DURING THE PROCEDURE OR REMOVAL FROM THE PATIENT. AN UNDAMAGED IN-HOUSE .014" TEST WIRE WAS LOADED THROUGH THE OAD WITHOUT ANY RESISTANCE. NO OTHER DAMAGE WAS NOTED TO THE GUIDE WIRE OR THE OAD THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A LOT NUMBER REVIEW WAS PERFORMED FOR LOTS 58689 FOR THE OAD AND 60851 FOR THE GUIDE WIRE AND NO ISSUES OR RECORDS OF SCRAP WERE IDENTIFIED. AT THE CONCLUSION OF THE FAILURE ANALYSIS INVESTIGATION, THE CAUSE OF THE DEVICE BECOMING STUCK ON THE WIRE WAS THE GUIDE WIRE BEND; HOWEVER, THE ROOT CAUSE OF THE DISSECTION EVENT REMAINS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, THE DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM BECAME STUCK ON THE VIPERWIRE. THE LESIONS BEING TREATED WERE 4 DIFFERENT FOCAL, VERY CALCIFIED LESIONS WITH 80-98% STENOSIS IN THE DISTAL SFA AND POPLITEAL ARTERIES. THE RIGHT SFA WAS ESTIMATED AT 6-7MM IN DIAMETER. THE PHYSICIAN USED A CONTRALATERAL APPROACH TO CROSS THE LESION, THEN A 1.5 SOLID CROWN OAD WAS USED TO TREAT ALL FOUR DIFFERENT LESIONS. HE ATTEMPTED TO REACH THE DISTAL LESION FIRST, RIGHT ABOVE THE AT TRUNK, BUT GOT CAUGHT UP IN THE THIRD LESION, WHICH WAS IN THE POPLITEAL, SO HE SPUN ON LOW FOR APPROXIMATELY 5 SECONDS TO GET THROUGH THE LESION. HE THEN TREATED THE FOURTH LESION ABOVE THE AT TRUNK. HE PERFORMED A RUN AT LOW SPEED FOR 25 SECONDS, THEN PRIME/FLUSH WAS USED AND HE WAITED TWO MINUTES. (HE WAITED TWO MINUTES BEFORE EACH RUN, EVERY TIME.) HE THEN PERFORMED A SECOND RUN AT MEDIUM SPEED. HE SUBSEQUENTLY MOVED UP TO THE POPLITEAL LESION AND PERFORMED A 25 SECOND RUN AT LOW SPEED, THEN WAITED, THEN PERFORMED A SECOND RUN AT MEDIUM SPEED. HE THEN MOVED UP TO THE LESION IN THE HUNTER'S CANAL AND PERFORMED A LOW SPEED RUN FOR 25-30 SECONDS. HE SUBSEQUENTLY PERFORMED THREE RUNS (LOW, MEDIUM AND HIGH SPEEDS) ON EACH OF THE TWO SFA LESIONS, STARTING WITH THE DISTAL LESION FIRST. AFTER THE FOLLOW-UP ANGIOGRAM, HE NOTICED THAT THE POPLITEAL LESION REMAINED STENOTIC, SO HE PERFORMED ONE MORE RUN AT MEDIUM SPEED FOR 25-30 SECONDS. HE THEN ATTEMPTED TO REMOVE THE DEVICE OVER THE WIRE, BUT WAS UNSUCCESSFUL. AFTER SEVERAL FAILED ATTEMPTS, HE DECIDED TO REMOVE THE CATHETER AND THE WIRE AS A UNIT. THE FOLLOW-UP ANGIOGRAM DEMONSTRATED A FLAP OR FLOW LIMITING DISSECTION IN THE POPLITEAL ARTERY WHICH HE REPAIRED WITH A STENT WITH GOOD RESULTS. THE PATIENT CONDITION REMAINED STABLE AND ASYMPTOMATIC THROUGHOUT AND FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40949 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INCORPORATED PRD-SC30-150 58689

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F SHEATH| 4F TAPERED COOK GUIDE CATHETER