BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABIOMED 14F INTRODUCER KIT FOR IMPELLA

    MDR report key: 9504739 · Received December 20, 2019

    Report

    Report Number
    1035166-2019-00124
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    November 26, 2019
    Report Date
    March 30, 2020
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1: B4, B5, G4, G7, H2, H6, AND H10: THE DEVICE WAS USED IN TREATMENT. THE DEVICE WAS DISCARDED AND NOT RETURNED FOR EVALUATION. THERE WAS NO SPECIFIC PERFORMANCE ISSUE RELATED TO FAILURE REPORTED BY THE USER. NO FURTHER INVESTIGATION IS REQUIRED. THE LOT NUMBER OF THIS DEVICE WAS NOT PROVIDED, THEREFORE NEITHER A REVIEW OF THE DEVICE HISTORY RECORED NOR COMPLAINT HISTORY COULD BE PERFORMED. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NO FURTHER FOLLOW-UP 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

    ADDITIONAL INFORMATION MD FELT THAT IT WAS JUST OOZING FROM THE SMALL 6FR SHEATH. ANGIOMAX WAS STARTED, 14FR IMPELLA SHEATH WAS PLACED. ANGIOMAX STOPPED, BALLOON PLACED AND ARTERY WAS REPAIRED. PATIENT HAD PCI WITHOUT IMPELLA SUPPORT. FIELD REP BELIEVE'S THE PERFORATION WAS CAUSED BY THE INITIAL STICK BY THE PHYSICIAN.

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACING AN OSCOR 14FR INTRODUCER (MATERIAL # 0052-3025, LOT # UNKNOWN) A PERFORATION IN THE FEMORAL ARTERY RESULTED AND A HEMATOMA FORMED. MEDICAL INTERVENTION - BALLOON INSERTED TO SPOT OF TAMPONADE. PERCUTANEOUS CORONARY INTERVENTION PERFORMED WITHOUT IMPELLA PUMP USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296030 ABIOMED 14F INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER DYB OSCOR INC. 0052-3025 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention