BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 041

    MDR report key: 2874213 · Received December 14, 2012

    Report

    Report Number
    3005168196-2012-00427
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 16, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE WIRE TIP BEYOND THE TEARDROP STRUCTURE HAS ITS CORE WIRE BROKEN AT THE DISTAL END OF THE TEARDROP AND IS ATTACHED BY ONLY THE WRAPPING WIRE. THERE ARE MULTIPLE BENDS IN THE BODY OF THE SEPARATOR BUT THESE APPEAR TO BE THE RESULT OF POST PROCEDURAL HANDLING. CONCLUSION: THE "STRETCHING" OF THE DISTAL TIP OF THE SEPARATOR NOTED IN THE COMPLAINT IS CONFIRMED. THE CAUSE WAS A BREAK IN THE CORE WIRE OF THE SEPARATOR. ALTHOUGH THE CAUSE OF THIS BREAK CANNOT BE DIRECTLY DETERMINED, THE HOOK IN THE BROKEN SEGMENT OF THE DISTAL WIRE SUGGESTS THAT THE SEPARATOR CONTINUED TO BE USED AFTER THE DISTAL TIP HAD FOLDED BACK UPON ITSELF, STRESSING THE CORE WIRE UNTIL IT BROKE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN INTERVENTION TREATING A MEDIA OCCLUSION ON THE RIGHT SIDE THE PHYSICIAN WAS USING A REPERFUSION CATHETER AND SEPARATOR 041. THE CLOT HAD BEEN RETRIEVED WELL BUT THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE SEPARATOR WAS STRETCHED TO 4 TIMES ITS LENGTH. THE PHYSICIAN CHANGED TO A NEW SEPARATOR 041 AND FINISHED THE INTERVENTION. THE PATIENT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 041 NRY NRY PENUMBRA, INC. F23622

    Patients

    Seq Age Sex Outcome Treatment
    1