BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABIOMED 14F INTRODUCER KIT FOR IMPELLA

    MDR report key: 8667046 · Received June 4, 2019

    Report

    Report Number
    1035166-2019-00047
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 7, 2019
    Report Date
    August 21, 2019
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00813502010664
    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: B4, D4, G4, G7, H2, H6, H10 AND H11 CORRECTED DATA D4: EXPIRATION DATE 01-NOV-2021 THE DEVICE WAS USED IN TREATMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE INVESTIGATION WILL FOCUS ON REVIEW OF PRODUCT DOCUMENTATION. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. PER QA PROCEDURE PREFORM OCCLUSION TEST PER PROCEDURE, LATEST REVISION. VISUAL INSPECTION: WITH THE NAKED EYE AT A DISTANCE OF 12" TO 18", INSPECT SIDEPORT ASSEMBLY FOR EXCESSIVE GLUE. A BEAD OF GLUE AROUND THE PERIMETER OF THE SIDEPORT TUBE TO HUB JOINT IS ACCEPTABLE. SMEARED GLUE ON SIDEPORT ASSEMBLY IS NOT ACCEPTABLE. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER: ASPIRATION AND SALINE FLUSHING OF THE SHEATH, DILATOR, AND VALVE SHOULD BE PERFORMED TO HELP MINIMIZE THE POTENTIAL FOR AIR EMBOLISM AND CLOT FORMATION. ASPIRATE ALL AIR FROM THE SHEATH VALVE ASSEMBLY BY USING A SYRINGE CONNECTED TO THE SIDEPORT. FLUSH THE INTRODUCER THROUGH THE SIDEPORT. IF THE INTRODUCER IS TO REMAIN IN PLACE DURING CATHETER POSITIONING AND TESTING, FLUSHING THE INTRODUCER VIA THE SIDEPORT PERIODICALLY WITH SALINE IS ADVISED. 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. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE 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

    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 AN INCIDENT OCCURRED DURING AN OUTPATIENT PROCEDURE IN THE CATH LAB, FOR HIGH RISK PCI (PERCUTANEOUS CORONARY INTERVENTION) ON (B)(6) 2019. PATIENT HAD SIGNIFICANT DISEASE IN HER ILIAC ARTERY AND DISTAL AORTA BUT THERE WAS NO PRIOR ANGIOGRAM THAT PRESENTED THIS BEFORE ATTEMPTING TO PLACE THE IMPELLA CP DEVICE ACROSS AORTIC VALVE. AS THE CP DEVICE WAS ADVANCED OVER THE .018 WIRE, IT MET RESISTANCE IN THE DISTAL AORTA. CP WAS REMOVED AND A PIGTAIL CATHETER WAS PLACED IN THE AORTA TO TAKE AN ANGIOGRAM. THAT REVEALED SIGNIFICANT DISEASE IN LEFT COMMON ILIAC, LEFT EXTERNAL ILIAC AND THAT THE OSCOR 14F X 13CM SHEATH WAS OCCLUDING FLOW TO THE LEFT DISTAL EXTREMITY. THE OCCLUSION LEAD TO LIMB ISCHEMIA AND THE NEED FOR A CUT DOWN IN THE OR WITH VASCULAR REPAIR AND PATCH. PATIENT'S PERIPHERAL ARTERIES ARE KNOWN TO BE CALCIFIED; OUTCOME OF PATIENT IS STABLE. DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462691 ABIOMED 14F INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER DYB OSCOR INC. 0052-3025 C1-15681 00813502010664

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention