BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK PERIPHERAL

    MDR report key: 21817082 · Received April 10, 2025

    Report

    Report Number
    3004742232-2025-00080
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 21, 2025
    Report Date
    June 6, 2025
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    UDI-DI
    10852528005824
    PMA / PMN Number
    K220568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, AND DETAILED ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SALINE SHEATH SEPARATION AND FLOW ISSUE ARE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT-SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED SALINE SHEATH SEPARATION AND FLOW ISSUE COULD NOT BE DETERMINED. THE OAD WAS RETURNED WITH THE SHEATH SEPARATED AT THE NOSE CONE. DETAILED ANALYSIS SHOWED THAT THE SHEATH HAD BEEN PROPERLY ASSEMBLED WITH EVIDENCE OF ADHESIVE IN THE NECESSARY LOCATIONS AND CORRECT SHEATH DEPTH. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. UPDATED: G3, G6, H2, H3, H6 H6: CODES 4755, 4118, 3233, AND 11 NO LONGER APPLY.

    Description of Event or Problem · 0

    A DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A 70% STENOSED POSTERIOR TIBIAL ARTERY (PT). WHEN THE OAD WAS IN VIVO, IT WAS OBSERVED THAT BLOOD WAS COMING BACK UP INTO THE DRIVESHAFT OF THE OAD AND EXITING ABOUT FOUR INCHES FROM THE OAD NOSECONE. THE PHYSICIAN DIDN'T HAVE SUPPORT TO MOVE THE OAD CROWN, SO THE OAD WAS REMOVED FROM THE PATIENT FOR ASSESSMENT. EX VIVO, IT WAS OBSERVED THE OUTER COVERING OF THE SPRING COILS LOOKED DISCONNECTED FROM THE OAD NOSECONE, AS IF IT HAD MOVED UP. THE SALINE SHEATH WASN'T THERE TO SUPPORT THE SPRING COILS AND BLOOD WAS EXITING THROUGH THAT SPOT. IT WAS POSSIBLE THE SHEATH DISCONNECTED WHILE ENTERING THE PATIENT, BUT IT WAS UNABLE TO BE CONCLUSIVELY DETERMINED IF THAT HAD BEEN THE CASE. DUE TO BLOOD BACKING UP, A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT AND NO CLINICALLY SIGNIFICANT DELAY. THE FLOW OF SALINE TO THE TIP OF THE OAD WAS CONSIDERED SUFFICIENT ENOUGH TO AVOID INJURY TO THE PATIENT. CONTRAST AND VASODILATORS WERE ADMINISTERED THROUGH THE OAD DURING THE PROCEDURE. FORWARD SALINE FLOW DID NOT STOP FOR ANY REASON DURING THE PROCEDURE.

    Description of Event or Problem · 0

    A DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A 70% STENOSED POSTERIOR TIBIAL ARTERY (PT). WHEN THE OAD WAS IN VIVO, IT WAS OBSERVED THAT BLOOD WAS COMING BACK UP INTO THE DRIVESHAFT OF THE OAD AND EXITING ABOUT FOUR INCHES FROM THE OAD NOSECONE. THE PHYSICIAN DIDN'T HAVE SUPPORT TO MOVE THE OAD CROWN, SO THE OAD WAS REMOVED FROM THE PATIENT FOR ASSESSMENT. EX VIVO, IT WAS OBSERVED THE OUTER COVERING OF THE SPRING COILS LOOKED DISCONNECTED FROM THE OAD NOSECONE, AS IF IT HAD MOVED UP. THE SALINE SHEATH WASN'T THERE TO SUPPORT THE SPRING COILS AND BLOOD WAS EXITING THROUGH THAT SPOT. IT WAS POSSIBLE THE SHEATH DISCONNECTED WHILE ENTERING THE PATIENT, BUT IT WAS UNABLE TO BE CONCLUSIVELY DETERMINED IF THAT HAD BEEN THE CASE. DUE TO BLOOD BACKING UP, A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT AND NO CLINICALLY SIGNIFICANT DELAY. THE FLOW OF SALINE TO THE TIP OF THE OAD WAS CONSIDERED SUFFICIENT ENOUGH TO AVOID INJURY TO THE PATIENT. CONTRAST AND VASODILATORS WERE ADMINISTERED THROUGH THE OAD DURING THE PROCEDURE. FORWARD SALINE FLOW DID NOT STOP FOR ANY REASON DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518774 DIAMONDBACK PERIPHERAL CATHETER, PERIPHERAL, ATHERECTOMY MCW CARDIOVASCULAR SYSTEMS INCORPORATED DBP-EX-125SOL145 542793 10852528005824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown