BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2991321 · Received March 6, 2013

    Report

    Report Number
    3005168196-2013-00088
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 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: THE CATHETER WAS BROKEN IN TWO PIECES. THE BREAK IS APPROXIMATELY (44.5 CM) FROM THE DISTAL TIP IN THE MID-SHAFT AREA. A 0.032" MANDREL WAS INSERTED THROUGH THE HUB (PSC032) BUT WAS UNABLE TO ADVANCE DISTALLY DO TO THE BREAK. THE BREAK OCCURRED APPROXIMATELY (5.0 CM) ABOVE THE MID-SHAFT JOINT AT ANOTHER MATERIAL JOINT. THIS CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE BREAK IN THE CATHETER OCCURRED AT A MATERIAL BOND. ALL UNITS TESTED FOR TENSILE STRENGTH AT THIS BOND PASSED AND ALL UNITS IN THIS LOT WERE 100% VISUALLY INSPECTED FOR DEFECTS AT THIS BOND. THEREFORE, IT IS UNLIKELY THAT THERE WAS AN ISSUE WITH THE PRODUCTION OF THE CATHETER AT THIS BOND. THE PHYSICIAN STATES THAT THE CATHETER WAS BROKEN WITHOUT FORCEFUL POWER. HOWEVER, THE COMPLAINT DESCRIPTION ALSO STATES THAT THE GUIDE CATHETER MOVED DURING THE CASE AND WAS REPOSITIONED. IF THERE WAS A KINK IN THE REPERFUSION CATHETER AND THE OPERATOR ATTEMPTED TO PUSH THE GUIDE CATHETER PASSED THE KINK, THIS MAY HAVE CAUSED ENOUGH TENSILE FORCE TO EXCEED THE TENSILE STRENGTH OF THE MATERIAL BOND AND BREAK THE CATHETER. 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) 2013, THE PATIENT WAS UNDERGOING TREATMENT FOR CEREBRAL INFARCTION BETWEEN BA AND PCA (P1). THE PHYSICIAN INSERTED THE PSC032 TO APPROACH THE BLOOD CLOT WITHOUT OUTSTANDING RESISTANCE. FOR SEVERE ARTERIOSCLEROSIS, A GUIDING CATHETER DROPPED FROM THE VA TO THE ARCH OF AORTA. WHEN HAVING THE GUIDING CATHETER MOVED UPWARD, THE PHYSICIAN RETRIEVED THE PSC032 AND THEN CONFIRMED IT RUPTURED. UK WAS ADMINISTRATED AFTERWARD AND SUCCEEDED IN RECANALIZATION. PHYSICIAN'S COMMENT: OPERATION WAS DONE AS USUAL WITHOUT FORCEFUL POWER. IT WAS RUPTURED GAPING; THEREFORE, KINK MIGHT HAVE OCCURRED ON RIFT, AND IT MAY HAVE EXPANDED. IT MAY BE POSSIBLE THAT THE MOTION OF GUIDING CATHETER DROPPED AFFECTED THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95302 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC. F26139

    Patients

    Seq Age Sex Outcome Treatment
    1