BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABIOMED 14F INTRODUCER KIT FOR IMPELLA

    MDR report key: 8298432 · Received February 1, 2019

    Report

    Report Number
    1035166-2019-00006
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    January 4, 2019
    Report Date
    February 28, 2019
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00813502011562
    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 FOR TREATMENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. PER PROCEDURE ABIOMED INTRODUCER SHEATH IN-PROCESS AND FINAL INSPECTION 9.2.2 VISUAL INSPECTION: USING 10X MAGNIFICATION, VERIFY THE TIP IS ROUND, NO FLASH PROTRUDING GREATER THAN 0.4 MM (0.016") AND NO FLASH WITH WIDTH (AROUND CIRCUMFERENCE) GREATER THAN 0.7 MM (0.028"), NO SPLITTING, CRACKS OR OTHER DAMAGES. SLIGHT DISCOLORATION FROM TIPPING PROCESS IS ACCEPTABLE. VERIFY PROPER TIP SHAPE ACCORDING TO DRAWING. 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. DILATORS, CATHETERS, AND PACING LEADS SHOULD BE REMOVED SLOWLY FROM THE SHEATH. RAPID REMOVAL MAY DAMAGE THE VALVE MEMBRANE RESULTING IN BLOOD FLOW THROUGH. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. 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.

    Description of Event or Problem · 0

    AS PER ADDITIONAL INFORMATION, THERE WAS LONGITUDINAL SPILT, TIP AND END INTACT OBSERVED IN INTRODUCER. IMPELLA PLACEMENT WAS ABANDONED AND PATIENT WAS SUPPORTED BY VA ECMO.

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION IS STILL IN POGRESS, FOLLOW UP REPORT WILL BE SUBMITTED IF WE FOUND ANY FURTHER ADDTIONAL INFORMTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ACCESS AT FEMORAL ARTERY INTRODUCER BREAK INTO 4 PIECES WHICH PROMOTED VASCULAR REPAIR. PATIENT SURVIVED AFTER SURGERY. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. NO OTHER ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92035 ABIOMED 14F INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER DYB OSCOR INC. 0052-3000 C1-15174 00813502011562

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention