BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOURGUIDE¿ STEERABLE SHEATH

    MDR report key: 17417438 · Received July 28, 2023

    Report

    Report Number
    1035166-2023-00080
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    February 8, 2023
    Report Date
    July 28, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE IS NO COMPLAINT AGAINST THE GUIDESTAR. THE DEVICE WAS USED IN A STUDY (FOR TREATMENT) AND NOT RETURNED FOR ANALYSIS. THERE WAS NO DEVICE PERFORMANCE RELATED FAILURE REPORTED BY THE USER. THIS EVENT IS RELATED TO PATIENT CONDITION. NO FURTHER INVESTIGATION IS REQUIRED. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. 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

    CUSTOMER REPORTED PATIENT HAS BLEEDING GROIN. THERE IS NO REPORTED PERFORMANCE ISSUE ASSOCIATED WITH THE GUIDESTAR. THE PATIENT IS A 72-YEAR-OLD MALE, THAT IS PART OF A POST-MARKET CLINICAL STUDY NAMED (B)(4) SECURE. DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT STARTING BLEEDING. IT IS UNKNOWN IF ANY BLOOD WAS LOST, AND WHEN THE BLEEDING OCCURRED. THE BLEED WAS RESOLVED WITH AN INTERVENTION WITH COMPRESSION BANDAGE AND STERI-STRIPS. THE PATIENT'S OUTCOME WAS REPORTED AS "RECOVERED/RESOLVED." THERE WAS NO MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023 AND DISCHARGED ON (B)(6) 2023. IT WAS REPORTED, IN THE OPINION OF THE INVESTIGATOR IN ACCORDANCE WITH THE LIST OF EXPECTED EVENTS IN THE INSTRUCTIONS FOR USE, THIS ADVERSE EVENT WAS EXPECTED AND, OR ANTICIPATED. CUSTOMER MADE MULTIPLE ATTEMPTS TO OBTAIN LOT NUMBER AND TO GET THE DEVICE BACK, BUT ATTEMPTS WERE NOT SUCCESSFUL.THE CUSTOMER REPORTED THE ROOT CAUSE OF REPORTING THIS EVENT APPROXIMATELY 5 MONTHS AFTER EVENT, WAS DUE TO HUMAN ERROR BY THE TEAM IN CHARGE OF SENDING THE NOTIFICATIONS (EVENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966918 TOURGUIDE¿ STEERABLE SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization