BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSPC2 DELIVERY CATHETER

    MDR report key: 15773816 · Received November 10, 2022

    Report

    Report Number
    3015970743-2022-00001
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 9, 2022
    Manufacturer
    CENTERPOINT SYSTEMS LLC.
    Product Code
    DQY
    PMA / PMN Number
    K190475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A LEAD IMPLANTATION PROCEDURE, THE SSPC DELIVERY CATHETER WAS PLACED NEAR THE PATIENT'S SEPTUM. THE PHYSICIAN TURNED THE CATHETER SO IT WAS NO LONGER NEAR THE SEPTUM, HOWEVER IN DOING SO THE TIP OF THE SSPC DELIVERY CATHETER CAME IN CONTACT WITH THE SEPTUM. ANGIOGRAPHY AND LEFT VENTRICULAR ANGIOGRAPHY WAS PERFORMED AND DEMONSTRATED A SEPTAL PERFORATION. NO FURTHER INTERVENTION WAS PERFORMED TO TREAT THE SEPTAL PERFORATION, AND THE PATIENT WAS DISCHARGED WITHOUT FURTHER INTERVENTION OR ADVERSE PATIENT EFFECTS. THE PHYSICIAN NOTED THAT THIS WAS AN ELDERLY PATIENT ON DIALYSIS AND HAD A THIN INTERVENTRICULAR SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199149 SSPC2 DELIVERY CATHETER CATHETER, PERCUTANEOUS DQY CENTERPOINT SYSTEMS LLC. 9182 CL11233

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other