BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT FOR IMPELLA®

    MDR report key: 18237297 · Received November 30, 2023

    Report

    Report Number
    1035166-2023-00129
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    October 3, 2023
    Report Date
    September 4, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672009786
    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

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

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1: B4, G3, G6, H2, H6, AND H11. NO PRODUCT WAS PROVIDED FOR ANALYSIS. THERE WAS BLOOD LOSS REPORTED AND THE PATIENT REQUIRED A BLOOD TRANSFUSION, 1 UNIT OF PACKED RED BLOOD CELL (PRBC). THE PATIENT WAS BROUGHT TO SURGICAL INTENSIVE CARE UNIT (SICU). CARE WAS WITHDRAWN THE NEXT DAY. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. NO CORRECTIONS OR CORRECTIVE ACTIONS WILL BE TAKEN. DEVICE WAS NOT RETURNED FOR ANALYSIS AND REVIEW OF THE MANUFACTURING DOCUMENTS DID NOT REVEAL ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THIS COMPLAINT IS NON-VERIFIABLE. 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

    WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER (MATERIAL # 0052-3021, LOT # DP17331). ON (B)(6) 2023, A 64-YEAR-OLD FEMALE PATIENT WAS PRESENTED TO PHYSICIAN WITH RIGHT HEART FAILURE. IT WAS REPORTED AN IMPELLA RP DEVICE WAS PLACED VIA RIGHT FEMORAL VEIN. TECHNIQUE USED FOR INSERTION WAS FOLLOWED ACCORDING TO IMPELLA RP INSTRUCTIONS FOR USE (IFU). WHEN REMOVING THE INTRODUCER, THE INTRODUCER SHEATH CRACKED, RESULTING IN OOZING FROM SHEATH DURING PROCEDURE. BEFORE LEAVING CATH LAB, THE PATIENT REQUIRED A BLOOD TRANSFUSION, (B)(4) UNIT OF PACKED RED BLOOD CELL (PRBC). THE PATIENT WAS BROUGHT TO SURGICAL INTENSIVE CARE UNIT (SICU). CARE WAS WITHDRAWN THE NEXT DAY (B)(6) 2023, AND PATIENT EXPIRED. PER END USER, CAUSE OF DEATH, CARE WAS NOTED TO BE WITHDRAWN FROM PATIENT. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136308 INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB OSCOR INC. 0052-3021 DP-17331 00885672009786

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R