BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.0 SOFT EXT PTFE

    MDR report key: 2990790 · Received March 5, 2013

    Report

    Report Number
    0002954917-2013-00028
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    July 7, 2012
    Report Date
    February 14, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, HEMATOMA IS NOTED AS POTENTIAL COMPLICATION ASSOCIATED WITH SUCH PROCEDURES IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE A RETRIEVER WAS USED FOR A LEFT INTERNAL CAROTID ARTERY (ICA) OCCLUSION. TWO PASSES WERE MADE WITH THIS RETRIEVER. AN ACUTE RIGHT SUBDURAL HEMATOMA WAS CONFIRMED POST OPERATION. THE PHYSICIAN COULD NOT EXCLUDE THE DEVICES FROM CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A RETRIEVER WAS USED FOR A LEFT INTERNAL CAROTID ARTERY (ICA) OCCLUSION. TWO PASSES WERE MADE WITH THIS RETRIEVER. AN ACUTE RIGHT SUBDURAL HEMATOMA WAS CONFIRMED POST OPERATION. THE PHYSICIAN COULD NOT EXCLUDE THE DEVICES FROM CONTRIBUTING TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93728 V 2.0 SOFT EXT PTFE CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening