BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.0 FIRM EXT PEBAX

    MDR report key: 3000346 · Received March 12, 2013

    Report

    Report Number
    0002954917-2013-00033
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    May 10, 2012
    Report Date
    February 28, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HEMORRHAGE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH SUCH PROCEDURES AND IS NOTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE, THE PROBABLE CAUSE OF THE EVENT IS ANTICIPATED PROCEDURAL COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING A THROMBECTOMY PROCEDURE THREE RETRIEVERS WERE USED IN A RIGHT INTERNAL CAROTID ARTERY (R-ICA) OCCLUSION. IT WAS REPORTED THAT DURING USE OF ONE OF THE RETRIEVERS, THE FILAMENT OF THE RETRIEVER BROKE. A DAY POST PROCEDURE, A SMALL ASYMPTOMATIC HEMORRHAGIC TRANSFORMATION WAS OBSERVED AT THE INFARCT AREA AND 36.0MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WERE ADMINISTERED INTRAVENOUSLY. THE PHYSICIAN STATED THAT THE FILAMENT OF THE RETRIEVER LIKELY BROKE WHEN IT GOT CAUGHT AT THE Y CONNECTOR DURING THE RETRIEVAL PROCEDURE AND THE HEMORRHAGE WAS POSSIBLY DUE TO REVASCULARIZATION. NO ADDITIONAL INFORMATION IS AVAILABLE

    Description of Event or Problem · 1

    DURING A THROMBECTOMY PROCEDURE, THREE RETRIEVERS WERE USED IN A RIGHT INTERNAL CAROTID ARTERY (R-ICA) OCCLUSION. IT WAS REPORTED THAT DURING USE OF ONE OF THE RETRIEVERS, THE FILAMENT OF THE RETRIEVER BROKE. A DAY POST PROCEDURE, A SMALL ASYMPTOMATIC HEMORRHAGIC TRANSFORMATION WAS OBSERVED AT THE INFARCT AREA AND 36.0MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WERE ADMINISTERED INTRAVENOUSLY. THE PHYSICIAN STATED THAT THE FILAMENT OF THE RETRIEVER LIKELY BROKE WHEN IT GOT CAUGHT AT THE Y CONNECTOR DURING THE RETRIEVAL PROCEDURE AND THE HEMORRHAGE WAS POSSIBLY DUE TO REVASCULARIZATION. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102835 V 2.0 FIRM EXT PEBAX CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention V 2.5 FIRM EXT (CONCETRIC MEDICAL)| V 3.0 FIRM EXT (CONCENTRIC MEDICAL)