BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMAGER II ANGIOGRAPHIC CATHETER

    MDR report key: 11996889 · Received June 14, 2021

    Report

    Report Number
    2134265-2021-06960
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 19, 2021
    Report Date
    July 26, 2021
    Product Code
    DQO
    UDI-DI
    08714729355755
    PMA / PMN Number
    K120893
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MANUFACTURER: UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS IMAGER II ANGIOGRAPHIC CATHETER WAS EXAMINED. VISUAL INSPECTION SHOWED DAMAGE IN THE FORM OF A RUPTURE APPROXIMATELY 51 CM FROM THE DISTAL END. A KINK JUST DISTAL TO THE RUPTURE WAS FOUND. A BEND ON THE CATHETER WAS SEEN 11 CM TO 12 CM FROM THE DISTAL END. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE NOTED DAMAGE, REVEALED NO OTHER DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HOLE IN THE CATHETER. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN A DIAGNOSTIC PROCEDURE. THE PATIENT WAS BEING TREATED FOR STENOSIS IN THE LEG. DURING THE PROCEDURE, AFTER THE SECOND OR THIRD INJECTION OF KM AT 1000PSI AND 15ML/SEC, A SHAFT HOLE WAS OBSERVED IN THE MIDDLE OF THE CATHETER. THE PROCEDURE WAS CANCELLED AS A RESULT OF THIS EVENT. SHORTLY AFTER THE PROCEDURE, THE PATIENT NOTICED A TINGLING SENSATION IN THEIR FOREARM WITH NO PULSE. EXAMINATION REVEALED THROMBOSIS IN THE FOREARM. THE THROMBOSIS WAS REMOVED MECHANICALLY, AND A PATCH WAS SUTURED. THE PATIENT WAS WELL POST PROCEDURE. THE PHYSICIAN SUSPECTS THAT THE WITHDRAWAL OF THE CATHETER MAY HAVE INJURED THE VESSEL WALL AND CAUSED THE THROMBOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HOLE IN THE CATHETER. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN A DIAGNOSTIC PROCEDURE. THE PATIENT WAS BEING TREATED FOR STENOSIS IN THE LEG. DURING THE PROCEDURE, AFTER THE SECOND OR THIRD INJECTION OF KM AT 1000PSI AND 15ML/SEC, A SHAFT HOLE WAS OBSERVED IN THE MIDDLE OF THE CATHETER. THE PROCEDURE WAS CANCELLED AS A RESULT OF THIS EVENT. SHORTLY AFTER THE PROCEDURE, THE PATIENT NOTICED A TINGLING SENSATION IN THEIR FOREARM WITH NO PULSE. EXAMINATION REVEALED THROMBOSIS IN THE FOREARM. THE THROMBOSIS WAS REMOVED MECHANICALLY, AND A PATCH WAS SUTURED. THE PATIENT WAS WELL POST PROCEDURE. THE PHYSICIAN SUSPECTS THAT THE WITHDRAWAL OF THE CATHETER MAY HAVE INJURED THE VESSEL WALL AND CAUSED THE THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892612 IMAGER II ANGIOGRAPHIC CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO 38260 0000142070 08714729355755

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention