BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 3090668 · Received May 2, 2013

    Report

    Report Number
    3005168196-2013-00161
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CATHETER IS BROKEN APPROXIMATELY (20.2 CM) DISTAL FROM THE HUB. THE BREAK SITE SHOWS THAT THE FRACTURE WAS A CLEAN BREAK. THIS BREAK OCCURRED AT A MATERIAL BOND. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT DESCRIBES THAT THE DEVICE WAS FOUND DAMAGED AFTER UN-PACKAGING. THE BREAK IN THE CATHETER IS DISTAL OF THE HUB APPROXIMATELY (20.2 CM). THIS LOCATION IS AT A MATERIAL JUNCTION. THE PRODUCT IS INSPECTED PRIOR TO PACKAGING AND ALL DAMAGED PRODUCTS ARE REJECTED. IF THE PRODUCT IS MIS-HANDLED DURING REMOVAL FROM THE PACKAGE THE CATHETER MAY BE DAMAGED OR BROKEN. IF THE FORCE ON THE CATHETER IS GREATER THAN THE TENSILE SPECIFICATION OF THE MATERIAL, THE CATHETER MAY BREAK. THE CATHETER BREAK LIKELY OCCURRED DUE TO EXCESS TENSILE FORCE PLACED ON THE CATHETER DURING REMOVAL FROM THE PACKAGING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    AFTER UNPACKING THE CATHETER FOR USE IN A CASE THE PHYSICIAN FOUND IT TO BE DAMAGED. IT WAS NOT USED IN THE PATIENT AND RETURNED TO THE DISTRIBUTOR BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192045 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC. F25726

    Patients

    Seq Age Sex Outcome Treatment
    1