BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABIOMED INTRODUCER KIT FOR IMPELLA®

    MDR report key: 12782603 · Received November 9, 2021

    Report

    Report Number
    1035166-2021-00130
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 19, 2021
    Report Date
    April 11, 2022
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00813502010558
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Product Problem
    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: THE DEVICE WAS USED FOR TREATMENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE INVESTIGATION WAS FOCUSED ON A REVIEW OF PRODUCT DOCUMENTATION. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. HOWEVER, FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED PRODUCT ISSUE. PER QA PROCEDURE ADELANTE S2S INTRODUCER SHEATH IN-PROCESS AND FINAL INSPECTION: SAMPLE SIZE: 100% INSPECTION 12.3 VACUUM LEAK TEST - PERFORM PRESSURE AND VACUUM LEAK TEST PER PROCEDURE. PER INSTRUCTIONS FOR USE (IFU): WHEN ASSEMBLING THE SHEATH AND DILATOR, CARE MUST BE TAKEN TO INSERT THE DILATOR TIP STRAIGHT THROUGH THE CENTER OF THE VALVE MEMBRANE IN ORDER TO PREVENT INADVERTENT PUNCTURING OF THE MEMBRANE. DILATORS, CATHETERS, AND PACING LEADS SHOULD BE REMOVED SLOWLY FROM THE SHEATH. RAPID REMOVAL MAY DAMAGE THE VALVE MEMBRANE RESULTING IN BLOOD FLOW THROUGH THE VALVE. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. IN ADDITION, THERE WAS NO NEW FAILURE MODE IDENTIFIED AND THE RISK REMAINS ACCEPTABLE. 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 · 0

    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 · 0

    IT WAS REPORTED PATIENT WAS PRESENTED TO THE PHYSICIAN, SUFFERING FROM A PE POST HIP SURGERY. IT WAS ATTEMPTED TO PLACE RP FOR SUPPORT. SIGNIFICANT BLEEDING AROUND SHEATH/ HEMATOMA NOTED AT SITE. CONTRAST INJECTED THROUGH R4 DIAGNOSTIC CATHETER INSERTED IN SHEATH. VESSEL TEAR/ DISSECTION NOTED ON FLUORO. PATIENT TRANSFERRED TO HYBRID ROOM. ECMO CANNULATION ON LEFT TO SUPPORT PATIENT. SURGICAL VESSEL REPAIR WITH PATCH FOR VENOUS TEAR. THE PATIENT WAS GIVEN 2 UNITS OF BLOOD. ANGIOGRAPHICALLY THE VESSEL DID NOT APPEAR CALCIFIED. THERE WAS SOME TORTUOSITY ON THE RIGHT VEIN. HEMOSTASIS WAS ACHIEVED WITH SURGICAL PATCH REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678225 ABIOMED INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB OSCOR INC. 0052-3021 C1-16187 00813502010558

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention