BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 17711481 · Received September 8, 2023

    Report

    Report Number
    1035166-2023-00099
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 29, 2023
    Report Date
    September 8, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT MALFUNCTION REPORTED; THEREFORE, PRODUCT WAS NOT RETURNED. THE COMPLAINT IS RELATED TO THE PATIENT. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. 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:: 1. DURING THE CASE, AFTER RF APPLICATION AROUND THE LIPV, CHANGE OF THE PATIENT EKG, TRANSLATING SIGNS OF HEART ATTACK OR CORONARY SPASMS (UNCERTAIN REASON) 2. STANDARDIZATION OF THE EKG AFTER 10 MINUTES. THE ABLATION WAS FINALIZED WITHOUT ANOTHER INCIDENT. 3. AROUND 1H 30 LATER, PATIENT PRESENTED STROKE SYMPTOMS. 4. NEUROLOGICAL SYMPTOMS HAVE DISAPPEARED AT THE END OF THE DAY. ADDITIONAL INFORMATION: DURING THE CASE, ALL DEVICES HAVE BEEN USED ACCORDING TO USAGE INSTRUCTIONS: ABLATION AT 15W DURING 45SEC FOR ANTERIOR PART AND 15SEC FOR THE POSTERIOR PART IN TOTAL, PATIENT RECEIVED 4 RF APPLICATION FOR A TOTAL OF 3MINUTES OF RADIOFREQUENCY. ACT MEASURED AT 365 DURING THE CASE. AN EXTERNAL SHOCK WAS PERFORMED AT THE END OF THE CASE TO RESTORE SINUS RHYTHM. FOLLOWING THE CASE, PATIENT HAD ADDITIONAL EXAM: CORONARY ANGIOGRAPHY WHICH APPEARED NORMAL CEREBRAL IRM: LESION WERE FOUND CONFIRMING THE STROKE DIAGNOSTIC. SUBMITTING FOR ADMINISTRATIVE PURPOSES - ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897670 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 DP-16674 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| H| R