BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOURGUIDE¿ STEERABLE SHEATH

    MDR report key: 16375486 · Received February 14, 2023

    Report

    Report Number
    1035166-2023-00009
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    November 18, 2022
    Report Date
    August 7, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00850232006031
    PMA / PMN Number
    K120459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED TO OSCOR FOR EVALUATION. OSCOR INC. HAS NO CORRECTIVE ACTION SPECIFIC TO THE PRODUCT MENTIONED ABOVE. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT, THEREFORE, THIS COMPLAINT IS NON-VERIFIABLE. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. 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 REPORT 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 DILATOR DOES NOT CONNECT TO THE GUIDE. THERE IS NOTHING THAT IT CAN STAY CONNECTED TO. THE DILATOR IS COMPLETELY LOOSE AND FREE RIDING AND IMMEDIATELY UPON TOUCHING ANYTHING AT THE END IT WILL SLIDE INSIDE OF THE GUIDE. THE PATIENT HAS NOT AND WILL NOT RECEIVE TREATMENT. THE HANDLE IS OUTSIDE OF THE PATIENT AND THE COMPLAINT IS ABOUT THE DILATOR-TO-GUIDE CONNECTION OUTSIDE OF THE PATIENT´S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388515 TOURGUIDE¿ STEERABLE SHEATH INTRODUCER, CATHETER DYB OSCOR INC. TG0654509 DP-15078 00850232006031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown