BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL-HYDRAULIC

    MDR report key: 8741331 · Received June 27, 2019

    Report

    Report Number
    3008264254-2019-00552
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    January 30, 2017
    Report Date
    June 3, 2019
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRD
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). MANUFACTURER ADDRESS: CODMAN AND SHURTLEFF, INC ((B)(4)). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008264254-2019-00550, 3008264254-2019-00551.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿ASSOCIATION OF PLASMA D-DIMER LEVEL WITH THROMBOEMBOLIC EVENTS AFTER ENDOVASCULAR COIL TREATMENT OF RUPTURED CEREBRAL ANEURYSMS¿. 11 PATIENTS WITH ACUTELY RUPTURED INTRACRANIAL ANEURYSMS WHO UNDERWENT ENDOVASCULAR BALLOON ASSISTED COIL EMBOLIZATION DEVELOPED SYMPTOMATIC THROMBOEMBOLIC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533391 COIL-HYDRAULIC NEUROVASCULAR EMBOLIZATION DEVICE KRD CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention