BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ASPIRATION CATHETER

    MDR report key: 17817810 · Received September 25, 2023

    Report

    Report Number
    MW5146136
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 31, 1923
    Report Date
    September 20, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AN 86 YEARS OLD UNDERGOING A DIAGNOSTIC HEART CATHETERIZATION PROCEDURE. PENUMBRA ASPIRATION CATHETER SNAPPED MID SHAFT AND BROKE INTO PIECES. BOTH PIECES REMOVED BY THE SURGEON. FINAL ANGIOGRAM PERFORMED TO ENSURE NOTHING WAS RETAINED. NO HARM TO PATIENT. CONFIRMED NOTHING WAS RETAINED. PRODUCT INFO - PENUMBRA CAT RX "KIT" INDIGO SYSTEM ASPIRATION TUBING, REF CATRXKIT, LOT F00006170, USE BY 2028-03-30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097709 PENUMBRA ASPIRATION CATHETER CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION QEX PENUMBRA, INC. CATRXKIT F0006170

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male