BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA REPERFUSI CATHETER AND SEPARATOR 032

    MDR report key: 1833891 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00229
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: TWO 032 PENUMBRA SYSTEMS WERE RECEIVED. ALL UNITS WERE EVALUATED. ONE PSC032 HAD A SERIES OF KINKS ON THE DISTAL END. THE OTHER CATHETER HAD NO VISUAL DAMAGE. THE DISTAL TIP OF ONE OF THE 032 SEPARATORS HAD A PERMANENT BEND ON THE DISTAL TIP AND THE OTHER WAS SEPARATED AT THE PROXIMAL TRANSITION ZONE. CONCLUSION: THE CAUSE OF THE BENT SEPARATOR MAY HAVE BEEN THAT THE DEVICE WAS FORCED THROUGH THE CATHETER, IN ADDITION TO THE CYCLING MOVEMENT WHICH MAY HAVE CAUSED THE SEPARATOR TO BECOME FATIGUED AND BEND. THE ROOT CAUSE OF THE SECOND SEPARATOR BREAK MAY HAVE BEEN ASSOCIATED WITH THE PHYSICIAN RETRACTING THE SEPARATOR TO A POINT WHERE THE PROXIMAL TAPER EXITS THE RHV. WHEN THE PHYSICIAN ADVANCES THE SEPARATOR, THE SMALLER DIAMETER WORKING ZONE BENDS TO A POINT WHERE IT HOLDS THE BEND. FURTHER CYCLING MAY HAVE CAUSED THE BEND TO WEAKEN TO THE POINT OF SEPARATION. THE DHRS OF THIS MANUFACTURING LOTS HAVE BEEN REVIEWED AND A COPY IS ATTACHED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 0854 (LOT # L13170). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT # L13170) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS POST HUB MOLDING AND (B)(4) VISUAL REJECTS POST COATING. NO CONFORMANCES WERE ASSOCIATED WITH THIS LOT. THE LOT HAS PASSED ALL DIMENSIONAL MEASUREMENTS PER SPECIFICATION, IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN TRIED TO USE A PENUMBRA SYSTEM 026 AND SAID THAT THE SEPARATOR WOULD NOT PASS THROUGH THE CATHETER AT ABOUT THE MIDPOINT. THE PHYSICIAN THEN DECIDED TO REMOVE THE SYSTEM AND TRY TO WORK WITH THE PENUMBRA SYSTEM 032. HE WAS ABLE TO CLEAR THE M1 SEGMENT BUT THE PATIENT KEPT RE-THROMBOSING. THE TIP OF THE CATHETER BECAME FATIGUED AND FRAYED. THE PHYSICIAN THEN DECIDED TO USE ANOTHER PENUMBRA SYSTEM 032 AND AFTER ONE PASS, THE SEPARATOR BROKE AT THE PROXIMAL TRANSITION POINT. NOTE: SEE MDR 3005168196-2010-00028 FOR INFORMATION REGARDING THE PENUMBRA SYSTEM 026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA REPERFUSI CATHETER AND SEPARATOR 032 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F13170

    Patients

    Seq Age Sex Outcome Treatment
    1