BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 15540064 · Received October 4, 2022

    Report

    Report Number
    1035166-2022-00107
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    May 25, 2022
    Report Date
    February 9, 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 NOT RETURNED FOR ANALYSIS. THERE IS NO COMPLAINT AGAINST THE GUIDESTAR. LOCATION OF THE DEVICE IS UNKNOWN. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE DEVICE PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THE DEVICE WAS USED IN 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. 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 HELIOSTAR BALLOON AF ABLATION PROCEDURE A CARDIAC TAMPONADE OCCURRED MOST LIKELY DUE TO CATHETER/SHEATH MANIPULATION WHILST IN THE LEFT ATRIUM; BLOOD PRESSURE DROPPED WITH SLIGHT BRADYCARDIA HOWEVER NO TACHY ARRHYTHMIAS SEEN. PERICARDIOCENTESIS PERFORMED BUT UNABLE TO STABILIZE THE PATIENT; SURGEONS WERE CALLED IN AND THE PATIENT WAS TRANSFERRED TO THEATRES FOR OPEN HEART SURGERY. CASE ABANDONED, NO ABLATIONS PERFORMED; THERE WAS NO DIFFICULTY SEEN DURING THE TRANSEPTAL PUNCTURE AND THERE ARE NO PRODUCT ISSUES REPORTED. CUSTOMER REPORTED EVENT WAS PATIENT RELATED. PATIENT IS STILL IN ITU POST-SURGERY, INTUBATED BUT PLANNING TO EXTUBATE THIS WEEK. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540690 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 DP15888 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R