BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1961013 · Received January 11, 2011

    Report

    Report Number
    3004742232-2010-00006
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    March 24, 2010
    Report Date
    March 24, 2010
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE WAS DISCARDED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED REQUIRING PLACEMENT OF A STENT. THE LESION BEING TREATED WAS 70% OCCLUDED, HEAVILY CALCIFIED, 30 MM LONG AND LOCATED IN THE SFA. THE PHYSICIAN PERFORMED A CUT-DOWN FOR AN ANTEGRADE APPROACH. HE USED A 7F SHEATH, A VPR-GW-17 VIPERWIRE AND A DBG-SCT30-200 DIAMONDBACK OAD. HE SPUN ON LOW FOR 30 SECONDS DOWN AND BACK WITH NO DIFFICULTY, THEN ON MEDIUM FOR 30 SECONDS DOWN AND BACK WITH NO DIFFICULTY, THEN AT 110 RPMS FOR 30 SECONDS DOWN WITH NO DIFFICULTY. THE CROWN PASSED THROUGH LESION FINE, BUT WHEN THE PHYSICIAN PULLED IT BACK PROXIMALLY, IT STOPPED. HE WAS ABLE TO PULL IT BACK WITHOUT DIFFICULTY AND PERFORMED AN ANGIOGRAPH WHICH INDICATED THAT THE VESSEL WAS PERFORATED AND THE VESSEL APPEARED BULBOUS IN SHAPE. THE PHYSICIAN INFLATED A 5.0 BALLOON TWICE TO 8 ATMS FOR 1 MINUTE EACH TO TREAT THE PERFORATION. THERE WAS NO RESIDUAL PERFORATION OR STAINING OUTSIDE OF THAT AREA FOLLOWING THE ANGIOPLASTY. BECAUSE THE VESSEL HAD "LOOKED ANEURISMAL" HE THEN PLACED A VASCULAR STENT. THE PATIENT REMAINED STABLE THROUGHOUT THIS EVENT. NO RESPONSE FROM PHYSICIAN TO THREE WRITTEN REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS, INC. DBG-SCT30-200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention