BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 16373179 · Received February 14, 2023

    Report

    Report Number
    1035166-2023-00018
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    January 24, 2023
    Report Date
    November 28, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED IN TREATMENT. THE DEVICE WAS DISCARDED; THEREFORE, IT WAS NOT RETURNED FOR ANALYSIS. THERE IS NO COMPLAINT AGAINST THE GUIDESTAR. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE DEVICE PASS ALL IN-PROCESS AND QA FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. THERE WAS NO DEVICE PERFORMANCE RELATED FAILURE REPORTED BY THE USER. THIS EVENT IS RELATED TO PATIENT CONDITION. NO FURTHER INVESTIGATION IS REQUIRED. NO FURTHER FOLLOW-UP IS REQUIRED. THE DEVICE WAS NOT RETURNED AND THERE WAS NO SPECIFIC PERFORMANCE RELATED FAILURE REPORTED BY THE USER. BASED ON THE INVESTIGATION, A CAPA IS NOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN AFIB PROCEDURE, A PERICARDIAL FLUID WAS OBSERVED. AN ADDITIONAL SURGERY FOR LESS THAN ONE HOUR WAS REQUIRED FOR A BLOOD TRANSFUSION. ADJUVANT DRUG THERAPY BY ANESTHESIA AND PRESSURE MONITORING. PERICARDIOCENTESIS WAS PERFORMED. PATIENT WAS STABLE AND UNDER CONTROL. ALONG WITH THIS GUIDESTAR, THESE ADDITIONAL DEVICES WERE USED IN THIS PROCEDURE HELIOSTAR, LASSOSTAR, SWARTZ SHEATH LAMP AND FOUR BRK NEEDLES. IT WAS REPORTED ALL DEVICES USED IN THIS PROCEDURE WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681818 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 DP16211 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R