BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH

    MDR report key: 9452435 · Received December 11, 2019

    Report

    Report Number
    1035166-2019-00118
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    November 12, 2019
    Report Date
    February 7, 2020
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00643169530591
    PMA / PMN Number
    K101497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED FOR TREATMENT. THERE WAS NO PRODUCT PERFORMANCE ISSUE REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE INVESTIGATION WILL FOCUS ON THE DOCUMENTATION REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICES PASSED ALL APPLICABLE IN PROCESS AND FINAL INSPECTIONS BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS THERE WAS NO ISSUE REPORTED FOR THE DEVICE PERFORMANCE OR QUALITY. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. 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 · 1

    OUR INVESTIGATION IS STILL IN PROGRESS ,FOLLOW UP REPORT WILL BE SUBMITTED IF WE FIND ANY FURTHER ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CRYO ABLATION PROCEDURE PATIENT HAD LOW BLOOD PRESSURE. THE PHYSICIAN CONCLUDED THE PATIENT HAD A PERICARDIAL EFFUSION RESULTING FROM CARDIAC TAMPONADE. THE REASON FOR AND TIME OF THE TAMPONADE IS UNKNOWN. A PERICARDIOCENTESIS WAS PERFORMED, SUCCESSFULLY INCREASING THE BLOOD PRESSURE, BUT IT DID NOT STOP THE BLEEDING. THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY TO STOP THE BLEEDING AND CLOSE THE TAMPONADE; THE BLEEDING WAS STOPPED SUCCESSFULLY BUT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING AND HEMODIALYSIS WAS PERFORMED. THE PATIENT PASSED AWAY DURING THE NIGHT. DATE OF DEATH IS (B)(6) 2019. CAUSE OF DEATH IS CARDIAC TAMPONADE LEAD TO PERICARDIAL EFFUSION. THE REASON AND THE TIME OF THE TAMPONADE IS UNKNOWN. NO ADDITIONAL INFORMATION AVAILABLE. NO PRODUCT MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244126 ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH INTRODUCER, CATHETER DYB OSCOR INC. 990061-070 C1-16799 00643169530591

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R