BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 1860464 · Received September 27, 2010

    Report

    Report Number
    3005168196-2010-00647
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THERE IS AN OVALIZATION BETWEEN 21 AND 23.8 CM FROM THE DISTAL TIP OF THE CATHETER. AT THE PROXIMAL END OF THE OVALIZATION, THERE IS A KINK. A 0.032" MANDREL WAS INTRODUCED INTO THE HUB OF THE CATHETER AND MOVED DISTALLY. THE MANDREL STOPPED JUST PRIOR TO THE MOST PROXIMAL KINK. A 0.026" MANDREL BEHAVED SIMILARLY. A 0.015" MANDREL PASSED THROUGH THE ENTIRE CATHETER ENCOUNTERING MINOR RESISTANCE. THIS CATHETER IS NON-FUNCTIONAL. CONCLUSION: BASED ON THE COMPLAINT DESCRIPTION AND FINDINGS DURING THE TECHNICAL EVALUATION OF THE DEVICE, IT IS LIKELY THAT THE REPERFUSION CATHETER OVALIZED IN THE PATIENT'S ANATOMY WHILE THE SEPARATOR WAS INSIDE, TRAPPING THE SEPARATOR BULB DISTAL OF THE KINK. THE BENDS IN THE SEPARATOR WIRE WERE THE RESULT OF MANIPULATING THE SEPARATOR WHILE THE BULB WAS IMMOBILIZED IN THE CATHETER. THE COMPLAINT DESCRIPTION OF EVENTS INDICATES THAT A PSS026 WAS SUCCESSFULLY USED WITH THIS CATHETER. THEREFORE, IT IS LIKELY THAT THE PSS026 WAS USED WITH THE PSC032 PRIOR TO THE OVALIZATION OF THE CATHETER THAT OCCURRED DURING USE WITH THE PSS032 WHICH TRAPPED THE SEPARATOR. 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 PSS032 WOULD NOT ADVANCE THROUGH THE PSC032 DURING THE PROCEDURE. THE PSS026 WOULD GO THROUGH THE PSC032 BUT NOT THE PSS032. A 6F SHEATH WAS USED AND THE PATIENT HAD MILD TORTUOSITY. THERE WAS AN OCCLUSION AT THE DISTAL M2 BRANCH. THE PHYSICIAN SAID THAT IT SEEMED LIKE A HARD CLOT AND THE PSS026 WOULD KEEP GOING INFERIOR TO THE CLOT AND COULD NOT ENGAGE THE CLOT. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00646.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 032 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F12691

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR