BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABIOMED INTRODUCER KIT FOR IMPELLA®

    MDR report key: 12233426 · Received July 27, 2021

    Report

    Report Number
    1035166-2021-00080
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    June 23, 2021
    Report Date
    December 21, 2021
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672009755
    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

    OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT ISBASED 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 DEVICE WAS USED IN TREATMENT. ONE HALF OF 23F ABIOMED AXILLARY WAS RETURNED FOR ANALYSIS. TRACES OF BLOOD WAS FOUND ON THE SHEATH. UPON RETURNED PRODUCT EVALUATION, THE SHEATH WAS OBSERVED TO BE PEELED THROUGH THE SCORE LINE. THE SCORE LINES WERE OBSERVED TO BE PROMINENT. LEAK TEST COULD NOT BE PERFORMED AS THE SHEATH WAS RETURNED PEELED. THE SHEATH SURFACE WAS OBSERVED ON HIGHER MAGNIFICATION USING A VERTEX AND NO HOLES, CRACKS AND GAPS WERE OBSERVED. THE SHEATH WAS OBSERVED TO BE WITHIN SPECIFICATIONS. FURTHER INVESTIGATION REVEALED THAT WALL THICKNESS OF THE SCORELINE HAS BEEN REDUCE TO IMPROVE THE PEEL STRENGTH. REDUCED WALL THICKNESS OF THE SCORELINE COULD HAVE MADE THE SHEATH SUSCEPTIBLE TO COLLAPSING WHEN USED WITH GRAFT LOCKS, AND THAT COULD HAVE CAUSED LEAKAGE. HOWEVER, ALL DEVICES THAT HAVE BEEN EVALUATED HAVE MET THE CURRENT DIMENSIONAL, VISUAL, AND FUNCTIONAL REQUIREMENTS IN THE 23F SHEATH PRODUCT SPECIFICATION. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. PER OPERATIONS PROCEDURE(S) ADELANTE, ADELANTE-S AND ADELANTE-S2 SHEATH EXTRUSION · APPROPRIATE EXTRUSION TOOL IS SELECTED FOR THE PART TO BE EXTRUDED AND IS INSPECTED PRIOR TO THE EXTRUSION RUN. · PEEL STRENGTH AND CRITICAL DIMENSIONS ARE VERIFIED ON EVERY 100TH EXTRUDED SHEATH AS PER PROCEDURE. PER ABIOMED INTRODUCER SHEATH IN-PROCESS AND FINAL SAMPLE SIZE: 100% INSPECTION · THE SHEATH IS INSPECTED WITH A NAKED EYE AT A DISTANCE OF 12" TO 18" TO ENSURE THE SHEATH IS FREE OF KINKS, CRACKS, SPLITS, SINKS AND ANY OTHER DAMAGES. LEAK TEST IS PERFORMED AS PER PROCEDURE. ABIOMED INSTRUCTIONS FOR USE (IFU) IS PROVIDED WITH THE PRODUCT. BASED ON THE INVESTIGATION, A CAPA WAS NOT REQUIRED. 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 ISBASED 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS PRESENTED TO THE PHYSICIAN WITH MULTIPLE COMORBIDITIES (PRESENTED WITH STEMI AND PEA ARREST) . THE PHYSICIAN REPORTED BEING UNABLE TO OBTAIN HEMOSTASIS AFTER SECURING THE GRAFT LOCKS. THE SHEATH WAS NOTED AS "MORE PLIABLE/COLLAPSIBLE." INTERVENTION WAS TAKEN TO SUTURE AROUND THE SHEATH, APPLY EXTRA CLAMPING, AND DELIVERY OF 2 UNITS OF BLOOD (30 - 45 MINUTE DELAY). THIS CASE WAS COMPLETED VIA RIGHT AXILLARY ARTERY INSERTION VIA A 10/30 HEMASHIELD GOLD GRAFT. THE PATIENT DID HAVE A HISTORY OF PAD OF ILIAC ARTERIES WHICH IS ONE OF THE REASONS WHY THE PHYSICIAN DECIDED TO PLACE THE PUMP AXILLARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130293 ABIOMED INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB OSCOR INC. 0052-3006 PQOC11880 00885672009755

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention