BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 20098889 · Received August 29, 2024

    Report

    Report Number
    3004742232-2024-00322
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 29, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC. (ABBOTT)
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONTINUATION: GUIDEWIRE, VIPERWIRE ADVANCE CORONARY FLEX TIP INFORMATION: MODEL NUMBER: GWC-12325LG-FT. CATALOG NUMBER: 7-10038-01. PRIMARY UDI NUMBER: (B)(4). DEVICE MANUFACTURE DATE: 16NOVEMBER2023. EXPIRATION DATE: 30NOVEMBER2025. THE OAD WAS RETURNED WITH THE GUIDE WIRE STUCK WITHIN THE DRIVESHAFT. ANALYSIS IDENTIFIED ADHERED BIOLOGICAL MATERIAL EMBEDDED WITHIN THE DRIVESHAFT FILAR NEAR THE CROWN WHICH CAUSED SIGNIFICANT RESISTANCE WHEN ATTEMPTING TO REMOVE THE WIRE. AFTER REMOVAL, THE WIRE COULD NOT PASS THROUGH THE ADHERED BIOLOGICAL MATERIAL. THE OCCLUDED AREA WAS REMOVED, AND THE WIRE PASSED THE REMAINING DRIVESHAFT AND HANDLE ASSEMBLY WITHOUT ISSUE. THERE WAS NO DAMAGE OBSERVED TO THE GUIDE WIRE CORE OR SPRING TIP THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. WHEN TESTED, THE OAD FUNCTIONED AS INTENDED WITH NO ABNORMALITIES OBSERVED. REVIEW OF THE DEVICE DATA LOG IDENTIFIED STALL AND SPEED-DROP EVENTS DURING THE PROCEDURE CONFIRMING THE OAD CROWN STOPPED SPINNING, HOWEVER, ANALYSIS DID NOT IDENTIFY ANY OAD DAMAGE THAT MAY HAVE CONTRIBUTED TO THE MATERIAL ACCUMULATION. THE MORPHOLOGY AND EXACT ROOT CAUSE OF THE ACCUMULATED BIOLOGICAL MATERIAL COULD NOT BE DETERMINED. 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 THIS GUIDEWIRE 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. H6 INVESTIGATION CONCLUSION CODE 22: THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE MANUAL STATES THAT VASCULAR DISSECTION IS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR AND/OR REQUIRE INTERVENTION WITH USE OF THE SYSTEM. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR PROXIMAL-TO-DISTAL TREATMENT OF A 70% STENOSED, HEAVILY CALCIFIED, 3MM-DIAMETER LESION IN RAMUS INTERMEDIUS ARTERY VIA FEMORAL APPROACH. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. FOLLOWING THE THIRD OR FOURTH LOW-SPEED TREATMENT, THE OAD CROWN STOPPED SPINNING. IT IS UNKNOWN IF THE LED LIGHTS OF THE OAD WERE ILLUMINATED. ONLY LOW-SPEED TREATMENTS WERE USED. ANGIOGRAPHIC IMAGES WERE TAKEN WHICH SHOWED THAT NOTHING MOVED WHEN THE OAD DRIVESHAFT WAS ATTEMPTED TO BE ADVANCED OR RETRACTED INDICATING THE OAD WAS STUCK ON THE VIPERWIRE. THERE WAS ENOUGH SALINE FLOWING. THE OAD WAS TURNED ON USING THE ON/OFF BUTTON AND PUT ON GLIDEASSIST FOR REMOVAL BUT STOPPED SPINNING AFTER A SECOND WITH THE LED LIGHTS ON. THE SAME THING HAPPENED WHEN THE ON/OFF BUTTON WAS TURNED ON AGAIN. THE POWER CORD CONNECTIONS WERE CONFIRMED TO BE GOOD, AND THE PUMP LED WAS GREEN. THE OAD AND THE VIPERWIRE WERE MANUALLY REMOVED TOGETHER. EX VIVO, THE OAD WAS FOUND STUCK ON THE VIPERWIRE. IT WAS DIFFICULT TO TELL WHAT TYPE OF DAMAGE EACH SUSTAINED WITHOUT SEPARATING THEM. THE OAD CROWN AND VIPERWIRE SPRING TIP WERE NOT NEAR EACH OTHER. ANGIOGRAPHIC IMAGING WAS TAKEN WHICH REVEALED A TYPE-B DISSECTION IN THE RAMUS ARTERY. THE DISSECTION WAS TREATED WITH 2.5MM-DIAMETER NON-ABBOTT STENT WITHOUT FURTHER COMPLICATION. THE ATHERECTOMY WAS DEEMED ADEQUATE. NO BALLOON ANGIOPLASTY WAS NEEDED. IN THE OPINION OF THE PHYSICIAN, CSI DEVICE CAUSED THE DISSECTION BUT DOES NOT KNOW IF IT WAS THE OAD OR VIPERWIRE. THE PHYSICIAN HAD NO INDICATION AS TO WHAT CAUSED THE OAD TO STOP SPINNING. THE CROWN DID NOT JUMP AND MAKE CONTACT WITH THE VIPERWIRE TIP. THE SALINE PUMP LED REMAINED GREEN THE ENTIRE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794355 DIAMONDBACK CORONARY CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DBEC-125 530182-1

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Required Intervention GUIDE WIRE, VIPERWIRE ADVANCE CORONARY FLEX TIP.