BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT FOR IMPELLA®

    MDR report key: 9417740 · Received December 5, 2019

    Report

    Report Number
    1035166-2019-00115
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    October 28, 2019
    Report Date
    February 6, 2020
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED IN TREATMENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE INVESTIGATION WILL FOCUS 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 PER PROCEDURE ABIOMED INTRODUCER SHEATH IN-PROCESS AND FINAL INSPECTION, THE DEVICES IN THIS LOT WERE INSPECTED AS FOLLOWS: VISUAL INSPECTION:VERIFY HUB TO BE SMOOTH, NO CRACKS, SHORT SHOTS, SINKING OR UNFILLED AREAS, AND CHECK FOR FM. VERIFY HUB SHAPE AS PER DRAWING. VERIFY FRENCH SIZE IS PROPERLY EMBOSSED ON HUB. CHECK FOR EXCESSIVE FLASH (MAXIMUM ALLOWABLE LIMIT IS 0.005") AND TUBE PINCH. USING 10X MICROSCOPE, LOOK DOWN INTO HUB FOR IRREGULARITIES. VERIFY NO SPLITTING AT BREAK LINES AND A SMOOTH TRANSITION BETWEEN SHEATH AND HUB ON INSIDE OF HUB. THIS IS PERFORMED BY QA ON THE FIRST 5 CONSECUTIVE PROPERLY TIPPED PARTS. WITH NAKED EYE AT A DISTANCE OF 12" TO 18", VERIFY THE ASSEMBLED SHEATH MATCHES THE DRAWING. ENSURE PARTS ARE FREE OF KINKS, CRACKS, SPLITS, SINKS, EXCESSIVE FLASH, LOOSE/EMBEDDED FM. THIS IS PERFORMED BY QA ON 100% OF THE SHEATHS. PER IFU : NEVER ADVANCE OR WITHDRAW GUIDEWIRE OR SHEATH WHEN RESISTANCE IS MET. DETERMINE CAUSE BY FLUOROSCOPY AND TAKE REMEDIAL ACTION. WHEN INJECTING OR ASPIRATING THROUGH THE SHEATH, USE THE SIDEPORT ONLY. AVOID SUBJECTING THE DEVICE TO UNUSUAL STRESSES. 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 · 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 DURING INSERTION OF IMPELLA CP,14 FR PEEL AWAY INTRODUCER PEELED AWAY BEFORE IT WAS COMPLETELY REMOVED FROM THE BLOOD VESSEL. USER DID NOT REPORTED ANY PRODUCT MALFUNCTION. ACCESS SITE WAS LEAKING BLOOD AND LEAKAGE DID NOT STOP. AMOUNT OF BLOOD IS UNKNOWN AND THE PATIENT RECEIVED 18 UNITS OF RED BLOOD CELLS. PATIENT OUTCOME IS STABLE. IMPELLA WAS REMOVED ON 10/30. NO OTHER SERIOUS INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212832 INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB OSCOR INC. 0052-3025-JP C1-16769

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention