BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 19744158 · Received July 15, 2024

    Report

    Report Number
    3004742232-2024-00264
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 18, 2023
    Report Date
    August 12, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850026568117
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 0

    D10: PART NUMBER: 7-10038-01. MODEL NUMBER: GWC-12325LG-FT. UDI: (B)(4). LOT NUMBER: 523845-1. MFG DATE: 1/17/2024. THE OAD AND VIPERWIRE ADVANCE GUIDEWIRE WERE RETURNED FOR ANALYSIS. ANALYSIS OF THE OAD DETERMINED THERE WAS NO DAMAGE OR ABNORMALITIES OBSERVED WITH THE OAD DRIVESHAFT OR HANDLE ASSEMBLY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ANALYSIS OF THE VIPERWIRE OBSERVED A FRACTURE. SCANNING ELECTRON MICROSCOPIC (SEM) ANALYSIS OF THE FRACTURE FACE SHOWED NITINOL FATIGUE AND EVIDENCE OF ROTATIONAL WEAR ON THE SURFACE OF THE WIRE NEAR THE FRACTURE SITE. BENCH TESTING HAS SHOWN THAT EXCESSIVE WEAR BETWEEN THE GUIDE WIRE AND OAD TIP BUSHING MAY OCCUR DUE TO TORTUOSITY, TIGHT BENDS, AND/OR BUCKLING OF THE GUIDE WIRE DUE TO BEING ADVANCED AGAINST RESISTANCE WHICH COMPRESSES THE GUIDE WIRE INTO A BENT/BUCKLED SHAPE. IT IS POSSIBLE THE EXCESSIVE WEAR LED TO THE EVENTUAL FRACTURE OF THE GUIDE WIRE, HOWEVER, THIS WAS UNABLE TO BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER AND MATERIAL INSPECTION RECORD FOR THE GUIDE WIRE LOT NUMBER HAVE BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICES MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO PERFORM EIGHT LOW-SPEED TREATMENTS ON A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED RIGHT CORONARY ARTERY (RCA). AFTER THE TREATMENTS, A PERFORATION WAS OBSERVED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE. IT WAS OBSERVED THE VIPERWIRE ADVANCE GUIDE WIRE FRACTURED WHEN THE TIP PASSED THROUGH THE VESSEL. IT WAS INDICATED THIS WAS LIKELY DUE TO A KINK AND CONTACT WITH THE OAD. IN THE PHYSICIAN'S OPINION, THE KINK OCCURRED DUE TO THE ANGLE OF THE RCA. THE PHYSICIAN PINNED THE FRACTURED COMPONENT WITH A DRUG-ELUTING STENT. THE LENGTH OF FRACTURED COMPONENT LEFT IN THE PATIENT WAS 13 CM. THE PERFORATION RESOLVED WITH THE STENT, AND THE PROCEDURE WAS COMPLETE WITH TWO DRUG ELUTING STENTS BEING PLACED. A FEW HOURS AFTER THE PROCEDURE, AN ABDOMINAL BLEEDING WAS OBSERVED. THE BLEEDING WAS CONTROLLED, AND THE PATIENT STABILIZED WITHOUT MEDICATION. IN THE PHYSICIAN'S OPINION, THE ABDOMINAL BLEEDING WAS UNRELATED TO ORBITAL ATHERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257908 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 528154-1 10850026568117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O VIPERWIRE ADVANCE GUIDE WIRE.