BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOURGUIDE¿ STEERABLE SHEATH

    MDR report key: 16539815 · Received March 14, 2023

    Report

    Report Number
    1035166-2023-00040
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 27, 2023
    Report Date
    November 14, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00850232006055
    PMA / PMN Number
    K120459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THIS EVENT 1035166-2023-00040 (B)(4), IS A DUPLICATE OF REPORTED EVENT 1035166-2023-00039 (B)(4). NO FURTHER FOLLOW-UP IS REQUIRED. REPORT (B)(4) WILL BE VOIDED, SINCE IT IS A DUPLICATE AND WAS REPORTED TO OSCOR IN ERROR. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THIS EVENT WAS REPORTED IN ERROR, IT IS A DUPLICATE OF REPORTED EVENT 1035166-2023-00039 (B)(4).

    Description of Event or Problem · 0

    EVENT OCCURRED DURING PROCEDURE. HEALTHCARE PROFESSIONAL REPORTED THIS TOURGUIDE DILATOR DOES NOT CLICK AND CONNECT TO THE GUIDE. THE DILATOR REMAINS TOTALLY LOSE INSIDE THE GUIDE. THE PATIENT HAS NOT AND WILL NOT RECEIVE TREATMENT. THE ALLEGED EVENT HAS NOT BEEN RESOLVED. IT IS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT, THE REPRESENTATIVE WILL FOLLOW-UP. THE DEVICE WAS DISCARDED BY THE HOSPITAL. IT WAS REPORTED THIS COMPLAINT POTENTIALLY COULD BE A DUPLICATE COMPLAINT COMING FROM (B)(6), 1035166-2023-00039. THE CUSTOMER WILL NOT BE ABLE TO PROVIDE ANY ADDITIONAL INFORMATION UNTIL A FOLLOW-UP VISIT HAS BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739541 TOURGUIDE¿ STEERABLE SHEATH INTRODUCER, CATHETER DYB OSCOR INC. TG0704509 DP-17500 00850232006055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown