BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 20533763 · Received October 25, 2024

    Report

    Report Number
    3004742232-2024-00348
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    September 26, 2024
    Report Date
    November 7, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC. (ABBOTT)
    Product Code
    MCX
    UDI-DI
    10850026568698
    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. LOT NUMBER: 523846-1. PRIMARY UDI NUMBER: (B)(4). DEVICE MANUFACTURE DATE: 17JANUARY2024. EXPIRATION DATE: 31JANUARY2026. CSI ID (B)(4): THE GUIDE WIRE WAS RETURNED TO ABBOTT FOR ANALYSIS WITHOUT THE SPRING TIP AND FRACTURED AT THE PROXIMAL SPRING TIP SOLDER BOND. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE FRACTURE SHOWED EVIDENCE OF DUCTILE TORSION AND WEAR ON ONE SIDE OF THE FRACTURE FACE. THIS INDICATED THAT THE OAD MAY HAVE SPUN OVER THE FRACTURED EDGE OF THE GUIDE WIRE AFTER THE GUIDE WIRE SEPARATION. THIS IS CONSISTENT WITH COMPLAINT DETAILS WHICH STATED THAT IMAGING REVIEW SHOWED THE OAD WAS NO LONGER ADVANCING ALONG THE CURVE OF THE VESSEL AND THE GUIDE WIRE. THE CAUSE OF THE FRACTURE COULD NOT BE DETERMINED. 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. CSI ID (B)(4): ANALYSIS OF THE REPORTED DEVICE IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED: B4, G1, G3, G6, H2, H3, H6. CSI ID (B)(4): THE OAD WAS RETURNED WITH THE GUIDE WIRE NOT ENGAGED. ANALYSIS REVEALED AN OAD DRIVESHAFT KINK LOCATED PROXIMAL FROM THE CROWN CONFIRMING THE REPORTED COMPLAINT OF DRIVESHAFT KINK. REVIEW OF THE DEVICE DATA LOG SHOWED STALL EVENTS DURING THE PROCEDURE CONFIRMING THE REPORTED COMPLAINT OF STALL. THE CAUSE OF THE DEVICE STALLS AND DRIVESHAFT KINK 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. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE GUIDE WIRE WERE USED FOR TREATMENT OF HEAVILY CALCIFIED, 70-90% DIFFUSE (PROXIMAL, MID AND DISTAL), MODERATELY TORTUOUS, 4.0MM-DIAMETER LESION IN RIGHT CORONARY ARTERY VIA FEMORAL ACCESS. THE VIPERWIRE WAS ADVANCED WITH A GUIDING CATHETER DOWN THE POSTERIOR DESCENDING ARTERY (PDA) BRANCH. THE OAD WAS ADVANCED AND GLIDEASSIST WAS ACTIVATED. IMAGING WAS CHECKED. THE ABBOTT SALES REPRESENTATIVE ASKED THE PHYSICIAN TO STOP GLIDEASSIST AND REPOSITION THE VIPERWIRE MORE DISTALLY AND RETRACT THE OAD TO MAINTAIN PROPER DISTANCE. GLIDEASSIST WAS THEN REACTIVATED. THE OAD WAS SPUN TWO TO THREE TIMES FOR LOW-SPEED TREATMENTS. RETROGRADE TREATMENT WENT FINE, BUT WHEN TRYING TO TREAT ANTEGRADE STILL VIA FEMORAL ACCESS, THE OAD FELT LIKE IT BECAME STUCK IN THE VESSEL AND STALLED. THE OAD LED LIGHTS REMAINED ILLUMINATED. THEY PRIMED THE OAD AGAIN AND SUCCESSFULLY FREED THE OAD USING GLIDEASSIST. IMAGING REVIEW SHOWED THE OAD WAS NO LONGER ADVANCING ALONG THE CURVE OF THE VESSEL AND VIPERWIRE. A NEW VIPERWIRE WAS ADVANCED TO NOT LOSE WIRE POSITION. THE OAD AND THE INITIAL VIPERWIRE WERE REMOVED. EX VIVO, THE SPRING TIP ON THE VIPERWIRE WAS OBSERVED FRACTURED AND THE OAD DRIVESHAFT WAS BENT NEAR THE CROWN. THERE WAS NO TISSUE/PLAQUE OBSERVED ON THE OAD. IMAGING SHOWED THE FRACTURED SPRING TIP WAS LEFT IN A BRANCH OFF THE PDA. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE SPRING TIP. THE PATIENT WAS STABLE AND DOING WELL. THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL AS STANDARD PRACTICE. POST PROCEDURE, THE PHYSICIAN STATED THAT WHEN THEY INITIALLY STOPPED GLIDEASSIST AND HAD TO REPOSITION THE VIPERWIRE AND OAD WAS PERHAPS WHEN THE VIPERWIRE BECAME COMPROMISED, BECAUSE WHEN GLIDEASSIST WAS REACTIVATED, IT FELT LIKE IT WAS NOT RUNNING AS SMOOTHLY AS BEFORE. NO CROWN JUMPING WAS OBSERVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818811 DIAMONDBACK CORONARY CORONARY ORBITAL ATHERECTOMY SYSTEM MCX CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DBEC-125 532400-1 10850026568698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GUIDEWIRE, VIPERWIRE ADVANCE CORONARY FLEX TIP