BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 4203566 · Received October 27, 2014

    Report

    Report Number
    3004742232-2014-00050
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K133399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS THE OAD WAS RECEIVED WITH THE ORIGINAL GUIDEWIRE ENGAGED IN THE DEVICE. THE INITIAL VISUAL AND TACTILE EXAMINATION OF THE HANDLE ASSEMBLY, SALINE SHEATH AND DRIVESHAFT REVEALED A KINK IN THE DRIVESHAFT 6.5CM DISTAL TO THE NOSECONE ASSEMBLY. FURTHER EXAMINATION REVEALED THAT THE CROWN AND DISTAL TIP BUSHING REMAINED INTACT AND UNDAMAGED. ADHERED BIOLOGICAL MATERIAL WAS OBSERVED ON THE DRIVESHAFT AND CROWN. EXAMINATION OF THE DRIVESHAFT AND CROWN IN THIS AREA DID NOT REVEAL ANY DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE BIOLOGICAL MATERIAL ACCUMULATION. THE OUTSIDE DIAMETER OF THE CROWN AND CROWN LOCATION ON THE DRIVESHAFT WERE MEASURED AND MET THE DRAWING SPECIFICATIONS. THE DRIVESHAFT AND SALINE SHEATH LENGTHS WERE ALSO MEASURED AND MET THEIR RESPECTIVE DRAWING SPECIFICATIONS. THE INITIAL VISUAL AND TACTILE EXAMINATION OF THE EXPOSED SECTIONS OF THE GUIDEWIRE DID NOT REVEAL ANY DAMAGE. FURTHER EXAMINATION OF THE SPRING TIP AND PROXIMAL SOLDER BOND REVEALED THAT THEY REMAINED INTACT AND UNDAMAGED. BIOLOGICAL MATERIAL WAS OBSERVED ON THE PROXIMAL SPRING TIP COILS. THE GUIDEWIRE COULD NOT BE REMOVED DISTALLY FROM THE DRIVESHAFT. THE DRIVESHAFT AND GUIDEWIRE WERE DESTRUCTIVELY CUT JUST DISTAL TO THE KINKED SECTION. THE DISTAL GUIDEWIRE SECTION WAS THEN REMOVED FROM THE DRIVESHAFT SECTION. VISUAL AND TACTILE EXAMINATION OF THE REMAINING PROXIMAL SECTION OF THE GUIDEWIRE REVEALED ADHERED BIOLOGICAL MATERIAL ON THE SHAFT . THE PROXIMAL GUIDEWIRE SECTION WAS DESTRUCTIVELY REMOVED FROM THE HANDLE ASSEMBLY OF THE OAD. EXAMINATION OF THE GUIDEWIRE SECTION REVEALED A KINK IN THE SHAFT 148.0CM DISTAL TO THE PROXIMAL END. AN IN-HOUSE .014" TEST WIRE WAS LOADED THROUGH THE HANDLE ASSEMBLY. WHEN TESTED, THE OAD SPUN AT LOW, MEDIUM AND AT HIGH SPEED WITH NO ABNORMALITIES OBSERVED. AT THE CONCLUSION OF THE FAILURE ANALYSIS INVESTIGATION, THE ROOT CAUSE OF THE OAD BECOMING STUCK ON THE GUIDEWIRE WAS AN ACCUMULATION OF BIOLOGICAL MATERIAL ON THE DRIVESHAFT AND GUIDEWIRE. THE ROOT CAUSE OF THE PERFORATION COULD NOT BE DETERMINED. THE OAD AND ITS COMPONENTS WERE WITHIN SPECIFICATION AND THE OAD PERFORMED AS INTENDED DURING FUNCTIONAL TESTING. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE MATERIAL INSPECTION REPORT FOR THE VIPERWIRE WAS NOT REVIWED AS THE LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION OCCURRED. THE TARGET LESION WAS SEVERELY CALCIFIED, AND WAS LOCATED IN THE LEFT POSTERIOR TIBIAL ARTERY (L PTA). THE PHYSICIAN ADVANCED A CSI VIPERWIRE GUIDEWIRE INTO THE PATIENT AND LOADED A CSI ORBITAL ATHERECTOMY DEVICE (OAD) ONTO THE GUIDEWIRE. THE PHYSICIAN TREATED THE PROXIMAL AND MID PT ARTERY USING THE CSI OAD (FOUR RUNS AT LOW SPEED). THE PHYSICIAN THEN ATTEMPTED TO CROSS THE LESION ON MEDIUM, BUT THE OAD BOGGED DOWN IN THE LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE OAD, BUT DISCOVERED IT WAS STUCK ON THE GUIDEWIRE. THE OAD AND GUIDEWIRE WERE THEN REMOVED AS A UNIT. AT THIS POINT, THE PHYSICIAN NOTED A PERFORATION. THE PERFORATION WAS RESOLVED WITH MULTIPLE BALLOON INFLATIONS. THE PATIENT STATUS REMAINED STABLE THROUGH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681687 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS INCORPORATED DBP-125MICRO145 105552

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention