BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 13932489 · Received March 28, 2022

    Report

    Report Number
    3004742232-2022-00075
    Event Type
    Injury
    Date Received
    March 28, 2022
    Date of Event
    March 10, 2022
    Report Date
    March 28, 2022
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    UDI-DI
    10850000491189
    PMA / PMN Number
    K190634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE MANUAL STATES THAT NO REFLOW PHENOMENON IS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR AND/OR REQUIRE INTERVENTION WITH USE OF THE SYSTEM. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT 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:(B)(4).

    Description of Event or Problem · 0

    A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR USE VIA GROIN ACCESS FOR TREATMENT IN THE POSTERIOR TIBIAL (PT) AND LATERAL PLANTAR ARTERIES. THERE WAS MODERATE TORTUOSITY IN THE LATERAL PLANTAR ARTERY. THE VESSEL WAS 2.5MM IN DIAMETER AND 95% STENOSED WITH SEVERE CALCIFICATION. A RECOMMENDATION WAS MADE TO THE PHYSICIAN TO USE A SMALLER CROWN AND TO NOT ADVANCE THE OAD INTO THE LATERAL PLANTAR ARTERY, BUT THE SUGGESTION WAS NOT FOLLOWED. THE PT AND LATERAL PLANTAR WERE TREATED WITH LOW AND MEDIUM SPEEDS. A HIGH-SPEED TREATMENT WAS THEN PERFORMED IN THE PT. TREATMENTS WERE 25 SECONDS. MULTIPLE ATTEMPTS AT ANGIOPLASTY WERE MADE. THEREAFTER, THERE WAS NO FLOW DISTAL TO THE PEDAL ARCH. ANGIOPLASTY WAS APPLIED, AND AN ATTEMPT WAS MADE TO TREAT FROM THE ANTERIOR TIBIAL ARTERY THROUGH THE DORSALIS PEDIS IN ORDER TO ESTABLISH FLOW IN THE ARCH. NITROGLYCERIN WAS ALSO ADMINISTERED. IN THE OPINION OF THE PHYSICIAN, THE SPECIFIC CAUSE OF NO FLOW WAS SPASM AND PARTICULATE FROM OA. AS OF (B)(6) 2022, STRONG OUTFLOW HAD NOT BEEN REESTABLISHED. THE PATIENT UNDERWENT AN ADDITIONAL ANGIOGRAM AN ALTEPLASE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33432 DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC. DBP-125SOLID145 400937-1 10850000491189

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention