BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2974226 · Received February 22, 2013

    Report

    Report Number
    3005168196-2013-00080
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 23, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: ONE CATHETER (054) IS DAMAGED APPROXIMATELY (6.0CM) DISTAL OF THE HUB. A 0.054" MANDREL COULD NOT BE INSERTED IN TO THE HUB, BECAUSE OF THE TWISTED PROXIMAL SHAFT. THIS CATHETER IS NON-FUNCTIONAL. ONE CATHETER (032) IS DAMAGED APPROXIMATELY (55.4CM) FROM THE DISTAL TIP. A 0.032" MANDREL WAS INSERTED IN TO THE HUB AN ADVANCED DISTALLY UNTIL IT REACHED THE DAMAGED DISTAL PORTION OF THE CATHETER. THIS CATHETER IS NON-FUNCTIONAL. THE OTHER CATHETER (032) IS DAMAGED APPROXIMATELY (15.0CM) FROM THE DISTAL TIP. A 0.032 "MANDREL WAS INSERTED IN TO THE HUB AN ADVANCED DISTALLY UNTIL IT REACHED THE DAMAGED DISTAL PORTION OF THE CATHETER. THIS CATHETER IS NON-FUNCTIONAL. THE SEPARATORS (054) AND (032) ARE KINKED IN THE PTFE COATED SECTION OF THE WIRE. THE SEPARATOR (054) WIRE IS IN GOOD CONDITION. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. BASED ON THE OBSERVATIONS MADE DURING THE INVESTIGATION AND THE DESCRIPTION OF THE COMPLAINT, IT IS LIKELY THAT DURING WITHDRAW OF THE PSC032 FROM PSC054 THE PROXIMAL PORTION OF PSC054 SHAFT BELOW THE STRAIN RELIEF WAS KINKED. THIS MADE IT DIFFICULT TO INSERT BOTH 054 SEPARATORS. THE KINKS THAT APPEARED ALONG THE SHAFT OF PSC054 WOULD ALSO HAVE MADE IT IMPOSSIBLE FOR THE PHYSICIAN TO REINSERT ANY OF THE 032 CATHETERS. ALL OF THE DAMAGE SEEN IN THE 054 SEPARATORS, 032 CATHETERS, AND 032 SEPARATORS WAS LIKELY DUE TO THE INITIAL KINKS IN THE 054 CATHETER WHICH LIKELY OCCURRED DURING INSERTION AND MANIPULATION IN THE PATIENT. ONCE THE 054 CATHETER WAS KINKED, ALL OTHER DEVICES WHICH THE PHYSICIAN ATTEMPTED TO INSERT WOULD HAVE BEEN DIFFICULT TO ADVANCE AND EVENTUALLY BECOME DAMAGED DUE TO THE ATTEMPT TO INSERT AGAINST RESISTANCE. THE IFU FOR THE PENUMBRA SYSTEMS WARNS AGAINST USING DAMAGED DEVICES AND STATES NOT TO ADVANCE DEVICES AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS UNDERGOING TREATMENT FOR ACUTE CEREBRAL INFARCTION. THE PHYSICIAN PLACED THE PSC054 BY USING THE PSC032. AFTER WITHDRAWING THE PSC032, HE INSERTED THE PSS054 BUT IT GOT STUCK. ANOTHER NEW PSS054 WAS USED BUT GOT STUCK AS WELL. THE PHYSICIAN ATTEMPTED TO REUSE THE PSC032 BUT FAILED IN INSERTING, AND THEN OPENED ANOTHER NEW PSC032. THE PSS032 WAS INSERTED INTO THE PSC032; HOWEVER, IT STOPPED AROUND THIRTY CM FROM THE DISTAL SIMILARLY TO THE PS054. PTA WAS PERFORMED ALTERNATIVELY AND WAS SUCCESSFUL IN PARTIAL RECANALIZATION. FLATNESS ON THE PSC032, AND MULTIPLE KINKS ON THE PSC054 WERE CONFIRMED. MDRS 3005168196-2013-00075 - 00080 ARE ASSOCIATED WITH THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78671 PENUMBRA SYSTEM SEPARATOR 032 NRY NRY PENUMBRA, INC. F29913

    Patients

    Seq Age Sex Outcome Treatment
    1