BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELOCITY DELIVERY MICROCATHETER

    MDR report key: 2964222 · Received February 15, 2013

    Report

    Report Number
    3005168196-2013-00060
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 3, 2012
    Report Date
    January 16, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS EVENT WAS REPORTED DURING THE PENUMBRA SYSTEM SEPARATOR 3D CLINICAL TRIAL. THE INFORMATION AVAILABLE IS LIMITED TO PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL AND INFORMATION FROM THE CLINICAL TRIAL RESEARCH COORDINATORS. FURTHER CLARIFICATION HAS BEEN REQUESTED OF THE HOSPITAL AS TO THE DEVICE RELATIONSHIP TO THE EVENT HOWEVER, THE HOSPITAL HAS NOT PROVIDED ANY FURTHER DETAIL. THEREFORE, THIS MDR IS BEING SUBMITTED BECAUSE THE DEVICE RELATIONSHIP TO THE EVENT IS STILL CONSIDERED "UNCERTAIN". ANY ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL AS IT RELATES TO THIS EVENT WILL BE SUBMITTED IN A FOLLOW-UP MDR. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE NOT RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR TREATMENT OF ACUTE STROKE IN HER RIGHT MCA ON (B)(6) 2012 AND ENROLLED IN THE SEPARATOR 3D TRIAL AS A ROLL IN PATIENT, WITH TREATMENT BY THE SEPARATOR 3D DEVICE. THE THROMBUS WAS INITIALLY ACCESSED WITH THE PENUMBRA 5MAX CATHETER COAXIALLY OVER THE VELOCITY CATHETER. THE SEPARATOR 3D DEVICE WAS DEPLOYED AND TWO ATTEMPTS OF CLOT REMOVAL WITH ASPIRATION WAS PERFORMED WITH THE 5MAX CATHETER. AT THAT POINT, THE DECISION WAS MADE TO USE THE SOLITAIRE DEVICE, WHICH WAS THEN DEPLOYED THREE TIMES, THE THIRD TIME WITH 2 MG OF IA NICARDIPINE AND 1 MG OF IA LYTIC, RESULTING IN REVASCULARIZATION OF THE VESSEL. ON THE SAME DAY AS THE PROCEDURE, THE PATIENT SUFFERED FROM "NORMOCYTIC ANEMIA OF UNCLEAR ETIOLOGY" AND WAS GIVEN A BLOOD TRANSFUSION. THE EVENT REMAINS UNRESOLVED. THE EVENT WAS FIRST REPORTED IN OCTOBER, BUT THERE WAS NO DEEMED RELATIONSHIP TO THE STUDY DEVICE. ON (B)(6), IT WAS REPORTED IN THE EDC AS HAVING "UNCERTAIN" RELATIONSHIP TO THE STUDY DEVICE. THIS WAS FOLLOWED UP WITH EMAILS FOR CLARIFICATION TO THE STUDY TEAM, WITHOUT CLARIFICATION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00063.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67767 VELOCITY DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F28156

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention