BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 19119032 · Received April 16, 2024

    Report

    Report Number
    3004742232-2024-00170
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 20, 2024
    Report Date
    August 26, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491417
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: G3 - INCORRECT DATE RECEIVED BY MANUFACTURER SUBMITTED ON PREVIOUS REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION: B2 (ADDED HOSPITALIZATION AND OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS), H6 (ANNEX A, E, F). UPDATED FIELDS: B4, B5, D9, D10, G3, G6, H2, H3, H6 (ANNEX B, C, D). D10: CATALOG NUMBER: 7-10038-03; MODEL NUMBER: GWC-12325LG-FT; UDI: (B)(4); LOT NUMBER: 493887-1; MANUFACTURING DATE: 06/24/2023. THE OAD WAS RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE DATA LOG SHOWED EIGHT STALL EVENTS DURING THE PROCEDURE. THE DRIVESHAFT PORTION THAT WAS CUT/REMOVED WAS NOT RETURNED FOR ANALYSIS. ONLY CUT SECTIONS OF THE GUIDE WIRE WERE RETURNED, AND THE PORTION OF THE GUIDE WIRE THAT WAS FRACTURED WAS NOT RETURNED. THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ATTEMPT TO REMOVE THE FRACTURED COMPONENT ON (B)(6) 2024 WAS UNSUCCESSFUL. THERE WAS 8-10 CENTIMETERS LEFT OF THE FRACTURED DRIVESHAFT AND 13-15 CENTIMETERS OF FRACTURED GUIDE WIRE LEFT IN THE PATIENT. THE ABNORMAL BLOOD PRESSURE AND EKG READINGS WERE SPECIFIC TO BE TRANSIENT INFERIOR ST-ELEVATION AND BLOOD PRESSURE DROP TO 80/50 MMHG.

    Description of Event or Problem · 0

    A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED IN AN ATTEMPT TO TREAT A RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, THE OAD GLIDEASSIST WAS USED TO ADVANCE TO THE SEGMENT 3 NEXT TO DENSE STENOSIS. THE PATIENT EXPERIENCED ANGINA AND DURING ANGIOGRAPHY, TIMI 0-1 FLOW WAS FOUND DISTAL TO THE STENOSIS IN SEGMENT 2. GLIDEASSIST WAS USED TO BACK THE OAD INTO SEGMENT 2. THE OAD WAS USED TO PERFORM A FEW LOW-SPEED TREATMENTS PROXIMAL TO THE STENOSIS IN RETROGRADE AND ANTEGRADE DIRECTIONS. DISTAL FLOW IMPROVED AND THE PATIENT BECAME PAIN FREE. GLIDEASSIST WAS USED TO ADVANCE THE OAD TO THE DISTAL STENOSIS. DURING THIS, THE PATIENT HAD RENEWED ANGINA AND TIMI 0-1 FLOW WAS OBSERVED DISTALLY IN THE VESSEL. SEVERAL LOW-SPEED TREATMENTS WERE PERFORMED IN SEGMENT 3 IN THE ANTEGRADE DIRECTION. AN UNUSUAL NOISE WAS OBSERVED WITH THE CROWN. AFTER A FEW TREATMENTS, THE CROWN APPROACHED THE MOST DISTAL PORTION OF THE STENOSIS. SUDDENLY, THE CROWN JUMPED FORWARD AND A VIBRATION WAS FELT WITH THE OAD. THE OAD STALLED. THE PATIENT STATED THEY FELT BETTER, AND ANGIOGRAPHIC IMAGING ASSESS THAT TIMI FLOW WAS PRESENT. THE OAD WAS ATTEMPTED TO BE TURNED BACK ON WITH GLIDEASSIST ACTIVATED, HOWEVER, THE OAD CONTINUED TO SHUT DOWN. THE PHYSICIAN FELT VIBRATION WITH THE OAD ONCE AGAIN. ANGIOGRAPHIC IMAGING STILL SHOWED TIMI FLOW IN THE PERIPHERY OF THE VESSEL BUT A NEW DISCONTINUITY OF THE OAD WAS OBSERVED AT THE TRANSITION FROM SEGMENT 2 TO 3, APPROXIMATELY 3-4 CENTIMETERS PROXIMAL TO THE CROWN. THE PHYSICIAN ATTEMPTED TO REMOVE THE OAD, HOWEVER, IT APPEARED STUCK. SEVERAL ATTEMPTS TO BYPASS THE TRANSITION WITH NON-CSI/NON-ABBOTT DEVICES WERE MADE, BUT UNSUCCESSFUL. VARIOUS BALLOONS WERE ABLE TO BE ADVANCED. A BALLOON WAS GENTLY EXPANDED, AND FLOW IMPROVED SLIGHTLY. AT THIS TIME, THE PATIENT'S SYMPTOMS IMPROVED, ELECTROCARDIOGRAM (EKG) AND BLOOD PRESSURE READINGS NORMALIZED. SEVERAL ADDITIONAL ATTEMPTS WERE MADE TO MOBILIZE THE OAD TO WITHDRAW, BUT THEY WERE STILL UNABLE TO REMOVE THE OAD. IN THE PHYSICIAN'S OPINION, THE KINKING/TWISTING AND PARTIAL DETACHMENT OF THE OAD WITH ENTANGLEMENT BETWEEN SEGMENTS 2 AND 3 OF THE RCA IS WHAT LED TO THE OAD BECOMING STUCK. THE OAD WAS STILL ON THE VIPERWIRE AT THIS TIME. THE INTRODUCER, INCLUDING THE GUIDE CATHETER AND OAD WERE LEFT IN THE RIGHT GROIN OF THE PATIENT, WRAPPED IN STERILE PLASTIC AND SECURED. MEDICATION WAS ADMINISTERED AND THE PATIENT WAS IN STABLE CONDITION. THE PATIENT WAS TRANSFERRED TO A HOSPITAL, WHERE THORACIC SURGERY WAS TO BE PERFORMED. WHEN THE PATIENT ARRIVED FOR THORACIC SURGERY, THE PATIENT WAS HEMODYNAMICALLY UNSTABLE, MAINLY DUE TO A LARGE LEFT GROIN HEMATOMA CAUSED BY BLEEDING FROM THE PUNCTURE SITE. THE 6F INTRODUCER HAD DISLODGED FROM THE VESSEL DURING TRANSPORT TO THE HOSPITAL. THE BLEEDING WAS RESOLVED BY PROMPT ANGIOGRAPHY AND APPOSITION OF 2 COVERED STENTS IN THE COMMON FEMORAL ARTERY. THE RIGHT GROIN WAS MAINTAINED A 6F INTRODUCER WITH A 6F CORONARY GUIDING CATHETER AND A PLUGGED TUOHY Y-CONNECTOR. EXITING THE VALVE WAS WHAT WAS LEFT FROM THE OUTER CATHETER OF THE OAD, CUT FROM THE CONTROL UNIT. NO OAD DRIVESHAFT OR VIPERWIRE WERE OBSERVED UNTIL REMOVAL OF THE OUTER SHEATH, WHEN 10-15 CENTIMETERS OF THE OAD DRIVESHAFT AND 1CM OF THE VIPERWIRE WERE EXTENDING FROM THE SHAFT. MULTIPLE BALLOONS WERE ATTEMPTED TO BE USED TO REMOVE THE OAD DRIVESHAFT AND VIPERWIRE, BUT WERE UNSUCCESSFUL. A GUIDING CATHETER WAS USED IN AN ATTEMPT TO REMOVE THE OAD DRIVESHAFT, HOWEVER, THIS WAS UNSUCCESSFUL AS WELL. DURING HIGH-RESOLUTION CINE IMAGING, IT WAS OBSERVED THE DRIVESHAFT PROXIMAL TO THE CROWN HAD BEEN DEFORMED BUT NOT COMPLETELY DETACHED AND FIBERS WERE IMPEDING OVER THE WIRE ADVANCEMENT OF THE 5F CATHETER DESPITE BEING DILATED WITH LARGER BALLOONS PRIOR. A FINAL ATTEMPT TO REMOVE THE OAD WAS MADE WITH A MICROCATHETER, AND THIS FAILED AS WELL. IN THE SURGEON'S OPINION, THE TWISTED PORTION OF THE DEVICE WAS ANCHORED INTO THE VESSEL AND THERE WAS LARGE HEMATOMA IN THE VESSEL WALL. THE COMPONENT WAS LEFT IN THE PATIENT AND THE PATIENT WAS TO CONTINUE ON ANTICOAGULATION MEDICATION. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856257 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. C-2DB-CL125-135 508922-1 10850000491417

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R| O VIPERWIRE CORONARY ADVANCE GUIDE WIRE.