BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2192900 · Received July 25, 2011

    Report

    Report Number
    3005168196-2011-00290
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THERE IS AN OVALIZATION THAT EXTENDS FROM 0.7 TO 1.5 CM FROM THE DISTAL TIP AND A SECOND OVALIZATION BETWEEN 3.8 AND 4.3 CM FROM THE DISTAL TIP. THE DISTAL END OF THE CATHETER WAS INTRODUCED INTO A DEMONSTRATION PACKAGING TUBE AND COULD NOT BE ADVANCED INTO THE TUBE PAST 1.0 CM FROM THE DISTAL TIP. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE DAMAGE OBSERVED AGREES WITH THE DAMAGE REPORTED IN THE COMPLAINT. HOWEVER, GIVEN THE DIFFICULTY ENCOUNTERED INTRODUCING THE DAMAGED CATHETER INTO ITS PACKAGING TUBE, THE DAMAGE LIKELY OCCURRED DURING OR AFTER ITS REMOVAL FROM ITS 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

    THE HOSPITAL REPORTED THAT THE NEURON DELIVERY CATHETER 070 WAS DEFECTIVE. THE TIP WAS CRIMPED FROM PACKAGING, AND THE NEURON WAS NOT USED IN THE PATIENT. ANOTHER NEURON WAS USED SUCCESSFULLY FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 DQY PENUMBRA, INC. F20600

    Patients

    Seq Age Sex Outcome Treatment
    1