BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 4812138 · Received June 2, 2015

    Report

    Report Number
    2954740-2015-00121
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 24, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. ADDITIONALLY, THE DEVICE CAPTURED IN THIS REPORT, REPRESENTS AN UNKNOWN REVIVE THROMBECTOMY DEVICE THAT IS SIMILAR TO REVIVE PV. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT IT WAS IMPOSSIBILITY TO REMOVE THE CLOT WITH THE REVIVE SE. 2 ATTEMPTS WERE PERFORMED WITH THE REVIVE SE, BEFORE CHANGING THE DEVICE. A SOLITAIRE FR 6X30MM WAS USED IN SECOND ATTENTION AND HAS SUCCESSFULLY REMOVED THE CLOT. MICROCATHETER PROWLER 27 AND INTERMEDIATE CATHETER DAC 56 WERE USED. MANUAL ASPIRATION WAS PERFORMED THROUGH A SYRINGE OF 50CC. THE PATIENT TREATED FOR ATRIAL FIBRILLATION (VITAMIN K ANTAGONISTS). THE MAN ((B)(6)) WITH AN OCCLUSION OF THE LEFT MIDDLE CEREBRAL ARTERY, TREATED BY THROMBECTOMY 5 HOURS POST IV RTPA INFUSION. THE PATIENT WAS NOT PART OF THE REACT STUDY, AND THERE WAS NO COMPLAINT AGAINST THE PROWLER 27 MICROCATHETER. ALL GUIDELINES WERE FOLLOWED DURING USE AND PREP OF THE DEVICE, AND THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PRODUCT WAS NOT RECEIVED FOR ANALYSIS AND THE PRODUCT LOT WAS NOT AVAILABLE, THEREFORE NO ANALYSIS OR DHR COULD BE CONDUCTED. THE FAILURE REPORTED BY THE COSTUMER AS ¿DEVICE INEFFECTIVE¿ WAS NOT CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND DHR COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. HOWEVER, IT IS POSSIBLE THAT PROCEDURAL FACTORS AND PATIENT CONDITION APPEAR TO HAVE CONTRIBUTED TO THE EVENT; ADDITIONALLY, INSPECTIONS ARE IN PLACE THAT PREVENTS ANY DEVICE FROM LEAVING THE FACILITY WITH ANY TYPE OF DAMAGE. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTED INDICATED THAT IT WAS IMPOSSIBILITY TO REMOVE THE CLOT WITH THE REVIVE SE. 2 ATTEMPTS WERE PERFORMED WITH THE REVIVE SE, BEFORE CHANGING THE DEVICE. A SOLITAIRE FR 6X30MM WAS USED IN SECOND ATTENTION AND HAS SUCCESSFULLY REMOVED THE CLOT. MICROCATHETER PROWLER 27 AND INTERMEDIATE CATHETER DAC 56 WERE USED. MANUAL ASPIRATION WAS PERFORMED THROUGH A SYRINGE OF 50CC. THE PATIENT TREATED FOR ATRIAL FIBRILLATION (VITAMIN K ANTAGONISTS). THE MAN ((B)(6)) WITH AN OCCLUSION OF THE LEFT MIDDLE CEREBRAL ARTERY, TREATED BY THROMBECTOMY 5 HOURS POST IV RTPA INFUSION. THE PATIENT WAS NOT PART OF THE REACT STUDY, AND THERE WAS NO COMPLAINT AGAINST THE PROWLER 27 MICROCATHETER. ALL GUIDELINES WERE FOLLOWED DURING USE AND PREP OF THE DEVICE, AND THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356045 REVIVE - THROMBECTOMY DEVICE MICRUS THROMBECTOMY DXE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening