BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 17243151 · Received June 30, 2023

    Report

    Report Number
    1035166-2023-00069
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 7, 2023
    Report Date
    December 12, 2023
    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 EVENT OCCURRED DURING AN ATRIAL FIBRILLATION PROCEDURE, NOT IN A STUDY. NO FURTHER FOLLOW-UP IS REQUIRED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1: A2, A3, B4, B5, G3, G6, H2, H6, H10 AND H11. CORRECTION H6: CORRECT CLINICAL CODE SHOULD BE 2605 - PSEUDOANEURYSM. THE MODEL AND LOT NUMBER WERE 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 INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THERE WAS NO DEVICE PERFORMANCE ISSUE REPORTED, SO NO INVESTIGATION IS REQUIRED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN DEVICE MODEL AND LOT NUMBER; HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. 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

    ADDITIONAL EVENT INFORMATION WAS RECEIVED. THE EVENT OCCURRED DURING AN ATRIAL FIBRILLATION PROCEDURE, NOT IN A STUDY.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN A STUDY, DURING AN ATRIAL FIBRILLATION PROCEDURE, AND THE PATIENT EXPERIENCED A PSEUDOANEURYSM RIGHT GROIN. AND WAS ADMITTED IN THE HOSPITAL ON (B)(6) 2023 AND DISCHARGED ON (B)(6) 2023. THERE WAS AN INTERVENTION WITH IN-PATIENT OR PROLONGATION HOSPITALIZATION (PLACEMENT OF FEMOSTOP; PRESSURE BANDAGE; COSAFIX (B)(6) 2023), HOWEVER THERE WAS NO SURGERY, AND NO ADVERSE EFFECT REPORTED. PATIENT OUTCOME STATES RECOVERED AND RESOLVED; ADDITIONALLY, IT WAS REPORTED THERE WAS NO PRODUCT PERFORMANCE ISSUE. THE DEVICE WILL NOT BE RETURNED, AND CUSTOMER WAS NOT ABLE TO OBTAIN MODEL OR LOT NUMBER OF THE GUIDESTAR USED IN THE STUDY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED PSEUDOANEURYSM RIGHT GROIN. EXACT MODEL OF GUIDESTAR AND LOT NUMBER IS UNKNOWN, CUSTOMER TRYING TO OBTAIN THIS INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254215 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization| R