BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT FOR IMPELLA®

    MDR report key: 9850021 · Received March 18, 2020

    Report

    Report Number
    1035166-2020-00021
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 22, 2020
    Report Date
    March 19, 2020
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672009793
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP. B4,D4,G4,G7,H2,H10. CORRECTION : D4 : EXPIRATION DATE CORRECTED 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

    THE DEVICE WAS USED IN THE TREATMENT. THE DEVICE WAS DISCARDED AND NOT RETURNED FOR ANALYSIS. THERE WAS NO SPECIFIC PERFORMANCE RELATED FAILURE REPORTED BY THE USER. THE DEVICE HISTORY RECORD WAS REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE INPROCESS AND FINAL INSPECTIONS. NO FURTHER INVESTIGATION IS REQUIRED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NONCONFORMITY. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NO FURTHER FOLLOW-UP IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CARDIOGENIC SHOCK PROCEDURE, THERE WAS BLEEDING AT THE INSERTION SITE. USER REPORTED THAT THERE WAS NO ISSUE WITH INTRODUCER. THEY NOTICED EXCESSIVE BLEEDING AFTER GIVING HEPARIN FOR ANTICOAGULATION ONCE THE SHEATH WAS IN. THE FIRST CP WAS PLACED HAD EXCESSIVE BLEEDING IN THE RIGHT GROIN. THEN THE SECOND CP WAS PLACED IN THE LEFT GROIN ONCE THE FIRST CP WAS REMOVED FROM THE SHEATH. PATIENT LOSS 800ML BLOOD. TWO (2) UNITS OF RED BLOOD CELLS (RBCS) WERE GIVEN AND GORE SHEATH WAS PLACED FOR HEMOSTASIS IN RIGHT GROIN AND NEW CP IN LEFT GROIN. THE SHEATH WAS SUTURED TO THE SKIN. THE BLEEDING CAUSED A DELAY IN PUTTING THE RP IN, WHICH WE NEVER GOT TO BECAUSE OF THE CONDITION OF THE PATIENT. PATIENT WAS VERY SICK. PATIENT EXPIRED ON 22ND FEBRUARY FROM CARDIAC ARREST. THE PATIENT WAS IN CARDIAC STANDSTILL. THERE WAS NO PRODUCT MALFUNCTION REPORTED. DEVICE WAS DISCARDED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313925 INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB OSCOR INC. 0052-3025 C1-17964 00885672009793

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention