BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 16880979 · Received May 5, 2023

    Report

    Report Number
    3004742232-2023-00126
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 6, 2023
    Report Date
    May 5, 2023
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    UDI-DI
    10850000491295
    PMA / PMN Number
    K190634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OAD WAS RETURNED FOR ANALYSIS. ANALYSIS IDENTIFIED A DRIVESHAFT FILAR FRACTURE PROXIMAL TO THE CROWN. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED ON THE DRIVESHAFT AND THERE WAS EVIDENCE OF FATIGUE OBSERVED. IT IS POSSIBLE THE DEVICE WAS SPUN THROUGH A TIGHT BEND, WHICH CREATED HIGH STRESS ON THE DRIVESHAFT AT THE CROWN EDGE. THE EXACT ROOT CAUSE WAS UNABLE TO BE CONCLUSIVELY 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: 12971

    Description of Event or Problem · 0

    THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A COMMON FEMORAL PORFUNDA. DURING ADVANCEMENT OF THE OAD, IT WAS NOTED THERE WAS A VERY SHARP TURN IN THE VESSEL DUE TO THE CALCIFIED LESION. THE OAD STOPPED ADVANCING ABRUPTLY AFTER 5 TO 7 MILLIMETERS. UPON REMOVAL OF THE OAD, MATERIAL WAS OBSERVED ON THE OAD AFTER REMOVAL OF THE DEVICE. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. CSI RETURN DEVICE ANALYSIS OF THE OAD DETERMINED THE MATERIAL ATTACHED TO THE OAD WAS FROM THE DRIVESHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195275 STEALTH 360 ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC. PRD-SC30-200 463005-1 10850000491295

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male