BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL-THERMO MECHANICAL

    MDR report key: 8529075 · Received April 18, 2019

    Report

    Report Number
    2954740-2019-00544
    Event Type
    Injury
    Date Received
    April 18, 2019
    Report Date
    March 28, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). LOT #: THE PRODUCT LOT NUMBER IS NOT AVAILABLE. MANUFACTURE SITE: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008264254-2019-00546, 3008264254-2019-00547. 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿AN OPTIMAL VISUALIZATION OF A CEREBRAL ANEURYSM WITHOUT INTERFERENCE OF OTHER ARTERIES BY USING MODIFIED DOUBLE MICROCATHETER TECHNIQUE DURING ENDOVASCULAR EMBOLIZATION.¿ A (B)(6) FEMALE PATIENT WITH SUBARACHNOID HEMORRHAGE FROM ANTERIOR COMMUNICATING ARTERY ANEURYSM WHO UNDERWENT ANEURYSM COIL EMBOLIZATION WITH ORBIT GALAXY FILL,ORBIT GALAXY XTRASOFT, DELTAPAQ COILS HAS DEVELOPED SYMPTOMATIC CEREBRAL VASOSPASM IN THE 10TH DAY OF ILLNESS, PERCUTANEOUS CEREBROVASCULAR EXPANSION AND LUMBAR - ABDOMINAL CAVITY SURGICAL ARTERIOVENOUS SHUNT FOR HYDROCEPHALUS ON THE 25TH DAY OF ILLNESS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320336 COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention