BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELIVERY CATHETER SSPC3

    MDR report key: 19684505 · Received July 5, 2024

    Report

    Report Number
    2124215-2024-41653
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 16, 2024
    Manufacturer
    CENTERPOINT SYSTEMS
    Product Code
    DQY
    UDI-DI
    00810024671830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. THIS SUPPLEMENTAL CORRECTION REPORT WAS CREATED DUE TO INITIAL REPORT WAS SENT IN ERROR. BOSTON SCIENTIFIC DOES NOT HAVE REPORTING RESPONSIBILITIES ON THIS RECORD.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CATHETER WAS DISCONTINUED TO USE DUE TO HEMOSTASIS VALVE BROKE AND THE BACK FLOW OF BLOOD COULD NOT BE STOPPED. THE LEAD FELL OFF WHILE SLITTING THE CATHETER. PHYSICIAN STATED THAT THE CATHETER'S HEMOSTASIS VALVE WAS STIFFER THAN USUAL SO CUTTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CATHETER WAS DISCONTINUED TO USE DUE TO HEMOSTASIS VALVE BROKE AND THE BACK FLOW OF BLOOD COULD NOT BE STOPPED. THE LEAD FELL OFF WHILE SLITTING THE CATHETER. PHYSICIAN STATED THAT THE CATHETER'S HEMOSTASIS VALVE WAS STIFFER THAN USUAL SO CUTTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281428 DELIVERY CATHETER SSPC3 CATHETER DQY CENTERPOINT SYSTEMS 9183 CL12237 00810024671830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown