BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT FOR IMPELLA®

    MDR report key: 8768658 · Received July 8, 2019

    Report

    Report Number
    1035166-2019-00057
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    September 25, 2019
    Report Date
    September 27, 2019
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00813502010664
    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. THE INVESTIGATION WILL FOCUS ON A REVIEW OF PRODUCT DOCUMENTATION. THE DEVICE HISTORY RECORDS AND GUIDEWIRE INSPECTION SHEET WERE REVIEWED TO CONFIRM THAT THE DEVICES PASSED ALL APPLICABLE IN PROCESS AND FINAL INSPECTIONS. THERE WAS NO PRODUCT PERFORMANCE ISSUE REPORTED. GUIDEWIRE PASSED THROUGH DILATOR EASILY. BECAUSE OF TORTUOUS ARTERY GUIDEWIRE WAS NOT ABLE TO ADVANCE AROUND AORTA. 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 · 0

    IN FOLLOW UP 1 MDR , DATE OF THIS REPORT DATE OF REPORT WAS LEFT BLANK. IT SHOULD BE 09-25-2017. NO CHANGE IN DATE OF EVENT. 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, GUIDEWIRE PASSED THROUGH DILATOR EASILY. RESISTANCE NOTICED INSIDE THE PATIENT ARTERY. PATIENT WAS RESCHEDULED FOR SURGERY AND PATIENT IS DOING FINE.

    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 PATIENT WAS PRESENTED FOR VENTRICULAR TACHACHARDIA. DURING EP/ABLATION PHYSICIAN WAS ADVANCING THE GUIDEWIRE THROUGH THE INTRODUCER. GUIDEWIRE WOULD NOT ADVANCE AROUND ASCENDING AORTA. DIAGNOSTIC PIGTAIL WAS INSERTED, PRIOR TO THE INSERTION OF THE 0.035" GUIDEWIRE. ONCE PIGTAIL WAS INSERTED, 0.035 WOULD NOT ADVANCE AROUND ASCENDING AORTA. AGAIN, DYE SHOWED A LUMEN AND TORTUOUS ARTERY. EP CALLED FOR TEE WHICH SHOWED A BIG FLAP FROM DISSECTION OF SFA TO ASCENDING AORTA. IMPELLA WAS ABORTED AND WIRES REMOVED AND PERCLOSE X 2 FAILED AND SURGICAL CLOSURE WAS DONE AFTER MANUAL PRESSURE DID NOT YIELD GOOD HOMEOSTASIS. PROCEDURE WAS ABORTED AND PATIENT OUTCOME IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563604 INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB OSCOR INC. 0052-3025 C1-15213 00813502010664

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention