BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPS LOCATOR 3D DELIVERY CATHETER

    MDR report key: 19563563 · Received June 18, 2024

    Report

    Report Number
    3015970743-2024-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 18, 2024
    Manufacturer
    CENTERPOINT SYSTEMS LLC
    Product Code
    DQY
    UDI-DI
    00810024670123
    PMA / PMN Number
    K230363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INITIAL RECEIPT OF THE COMPLAINT, CENTERPOINT SYSTEMS REVIEWED THE PRODUCTION LOT HISTORY RECORD AND THE INFORMATION PROVIDED BY THE HEALTHCARE PROFESSIONAL AND DISTRIBUTOR. INITIAL INVESTIGATION DID NOT RESULT IN ANY IDENTIFIED ROOT CAUSES. FURTHER INFORMATION WAS REQUESTED, INCLUDING THE RETURN OF THE DEVICE. ADDITIONAL INVESTIGATION RESULTS, IF ANY, WILL BE REPORTED IN A FOLLOW-UP. PER THE INFORMATION PROVIDED BY THE THIRD PARTY (DISTRIBUTOR), THERE WAS NO ADVERSE IMPACT ON THE HEALTH OF THE PATIENT.

    Description of Event or Problem · 0

    RIGHT SIDED DUAL CHAMBER PACEMAKER WITH LEFT BUNDLE BRANCH AREA PACING. ONCE ACCESS WAS OBTAINED THE PHYSICIAN SHAPED THE CPS LOCATOR WITH THE DILATOR INSIDE. HE INTRODUCED THE CPS LOCATOR WITH THE DILATOR, THEN REMOVED THE DILATOR AND WENT IN WITH THE LEAD UNDER FLUORO AND NOTICED THAT THE CPS LOCATOR WAS BROKEN OFF INTO THE BODY. THE PHYSICIAN THINKS THAT SINCE THE TURNE OF SVC WAS ALMOST 110 DEGREES THAT WHEN THE INTRODUCER WAS REMOVED THE CPS LOCATOR BROKE. THERE WAS ABOUT 5 INCHES OF CPS LOCATOR LEFT IN THE BODY THAT WAS REMOVED WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124510 CPS LOCATOR 3D DELIVERY CATHETER Catheter, percutaneous DQY CENTERPOINT SYSTEMS LLC DS2C200-42 CL12372 00810024670123

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention