BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTH

    MDR report key: 20055361 · Received August 23, 2024

    Report

    Report Number
    3004742232-2024-00320
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 18, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS INC.
    Product Code
    MCW
    UDI-DI
    10850000491295
    PMA / PMN Number
    K190634
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. (B)(4).

    Additional Manufacturer Narrative · 0

    THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS RETURNED FOR ANALYSIS. DURING FUNCTIONAL TESTING OF THE RETURNED OAD, AN IN-HOUSE 0.014" TEST WIRE MET RESISTANCE DUE TO THE DRIVESHAFT DAMAGE 6CM FROM THE LAP WELD. THE TEST WIRE WAS BACK LOADED INTO THE HANDLE TO CONTINUE FUNCTIONAL TESTING. ANALYSIS IDENTIFIED A SEPARATED SALINE SHEATH AT THE STRAIN RELIEF WITH EVIDENCE OF BLOOD BACKED UP WITHIN THE SHEATH. REVIEW OF THE DEVICE DATA LOG SHOWED THAT THE FIRST SEVERAL SPIN ATTEMPTS ENDED IN A STALL EVENT. THERE WAS A TOTAL OF 36 SECONDS OF SPINNING ON LOW SPEED DURING THE PROCEDURE. IT IS UNKNOWN IF THE STALL EVENTS ARE RELATED TO THE REPORTED COMPLAINT. THE CAUSE OF THE STALLS WAS ALSO UNKNOWN. FRACTURED DRIVESHAFT FILARS WERE IDENTIFIED NEAR THE LAP WELD. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE FRACTURED FILAR FACES WAS UNABLE TO IDENTIFY THE CAUSE OF THE FRACTURE. THERE WAS POSSIBLE EVIDENCE OF FATIGUE PRESENT, BUT IT WAS UNCLEAR. THE DAMAGE ALIGNS WITH THE STRAIN RELIEF WITH THE KNOB FULL FORWARD. IT IS POSSIBLE THAT A BEND WAS PRESENT IN THE DRIVESHAFT WHILE SPINNING, CREATING AN ELEVATED STRESS ENVIRONMENT RESULTING IN THE FRACTURE. HOWEVER, THIS WAS UNABLE TO BE CONFIRMED AND THE ROOT CAUSE OF THE DAMAGE WAS UNKNOWN. 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. UPDATED FIELDS: B4, B5, D9, G3, G6, H2, H3, H6 (ANNEX E, B, C, D) & H11, CORRECTED FIELD: H6 (ANNEX A) CSI ID: (B)(4).

    Description of Event or Problem · 0

    A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF HEAVILY CALCIFIED, OVER 90% STENOSED LESIONS IN COMMON FEMORAL ARTERY (CFA) AND SUPERFICIAL FEMORAL ARTERY (SFA) VIA FEMORAL UP-AND-OVER APPROACH. INTRAVASCULAR ULTRASOUND (IVUS) INDICATED THAT THE VESSEL DIAMETER WAS 7.2 - 7.9MM. FOLLOWING A PROXIMAL-TO-DISTAL TREATMENT OF THE CFA, A SECOND TREATMENT ON LOW SPEED WAS ATTEMPTED, BUT THE OAD COULD NOT BE ADVANCED AND SEEMED TO BE STUCK ON THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE. ANGIOGRAPHIC IMAGING OBSERVED THAT THE OAD CROWN WAS NOT STUCK ON THE VIPERWIRE AS SUSPECTED. BLOOD WAS NOTICED BACKING UP INTO THE OAD SALINE SHEATH AT THE TIP OF THE OAD HANDLE AND THE OAD SALINE SHEATH WAS FOUND DAMAGED. THE NOSECONE OF THE ORBITAL ATHERECTOMY SYSTEM (OAS) WAS DAMAGED, WHICH STOPPED SALINE FLOW FROM CONTINUING THROUGH THE OAS SHEATH. THE PHYSICIAN HAD THE OAD HANDLE LAYING ON THE TABLE AND THERE WAS A STEP-UP FROM ITS LOCATION TO WHERE THE PATIENT WAS LYING DOWN. THE PHYSICIAN INADVERTENTLY PUSHED THE OAD HANDLE ON THE STEP DURING TREATMENT BREAKING THE SHEATH AT THE 90-DEGREE ANGLE WHERE THE OAD HANDLE, AND DRIVESHAFT MEET. THE OAD WAS FREED FROM THE VIPERWIRE AND REMOVED BY TURNING IT ON AND OFF USING THE ON/OFF BUTTON. THE VIPERWIRE REMAINED IN PLACE. THE OAD WAS REPLACED AND THE SAME VIPERWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE TO THE VIPERWIRE UPON REMOVAL. THE INITIAL OAD WAS INOPERABLE DUE TO THE SHEATH DETACHMENT AND THUS NO SALINE FLOW TO THE CROWN OF THE DEVICE. NITROGLYCERIN WAS ADMINISTERED THROUGH THE ORBITAL ATHERECTOMY SYSTEM (OAS) DURING THE PROCEDURE. THE PATIENT WAS STABLE.

    Description of Event or Problem · 0

    DURING ANALYSIS OF THE RETURNED STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), A DRIVESHAFT FRACTURE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699193 STEALTH PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS INC. PRD-SC30-200 517053-1 10850000491295

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention