BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR

    MDR report key: 18986213 · Received March 27, 2024

    Report

    Report Number
    1035166-2024-00020
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    February 16, 2024
    Report Date
    May 2, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THERE WAS NO DEVICE PERFORMANCE ISSUE REPORTED, SO NO INVESTIGATION IS REQUIRED. SEVERAL ATTEMPTS TO OBTAIN CLARIFICATION WERE MADE, HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 CUSTOMER REPORTED A 73 YR., MALE UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE AND POST PROCEDURE FOR PULMONARY VEIN ISOLATION (PVI) HAD BLEEDING FROM A FEMORALIS RIGHT SIDE, THE PATIENT OUTCOME WAS RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047773 GUIDESTAR INTRODUCER, CATHETER DYB OSCOR INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male