BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.0 FIRM EXT PEBAX

    MDR report key: 3133698 · Received May 29, 2013

    Report

    Report Number
    0002954917-2013-00074
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    December 12, 2012
    Report Date
    May 15, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, HEMORRHAGE IS A KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND IS NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING A THROMBECTOMY PROCEDURE A RETRIEVER WAS USED IN THE OCCLUDED RIGHT INTERNAL CAROTID ARTERY (R-ICA). IT WAS REPORTED THAT AN EXTRAVASATION THAT RESULTED IN A SUBARACHNOID HEMORRHAGE WAS CONFIRMED AT THE MIDDLE CEREBRAL ARTERY JUNCTION AREA. THE PHYSICIAN ADMINISTERED 20.7 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) IN RESPONSE TO THE EVENT. THE RELATIONSHIP BETWEEN THE DEVICE USED AND THE REPORTED PROCEDURAL EVENT IS UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT DIED DUE TO PNEUMONIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    DURING A THROMBECTOMY PROCEDURE, A RETRIEVER WAS USED IN THE OCCLUDED RIGHT INTERNAL CAROTID ARTERY (R-ICA). IT WAS REPORTED THAT AN EXTRAVASATION THAT RESULTED IN A SUBARACHNOID HEMORRHAGE WAS CONFIRMED AT THE MIDDLE CEREBRAL ARTERY JUNCTION AREA. THE PHYSICIAN ADMINISTERED 20.7 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) IN RESPONSE TO THE EVENT. THE RELATIONSHIP BETWEEN THE DEVICE USED AND THE REPORTED PROCEDURAL EVENT IS UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST PROCEDURE, THE PATIENT DIED DUE TO PNEUMONIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236317 V 2.0 FIRM EXT PEBAX CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R