BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1644767 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00137
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    September 26, 2007
    Report Date
    September 26, 2007
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE CATHETER BROKE 12.1 CM FROM THE DISTAL TIP. THE BREAK OCCURRED AT DIAMETER CHANGE BOND. THE CATHETER SHAFT APPEARS NECKED AT THE BREAK POINT. THE STAINLESS STEEL COIL UNRAVELED FROM THE DISTAL END. CONCLUSION: THE PHYSICIAN INFORMED PENUMBRA THAT THE PACKAGING TABS WERE NOT OPEN PRIOR TO REMOVING THE CATHETER FROM THE PACKAGING CARD. WITH THE DISTAL END SECURED TO THE CARD, THE FORCE OF THE ATTEMPTED REMOVAL CAUSED THE SHAFT TO BREAK. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED 12/31/2009. A REVIEW OF THE DESIGN HISTORY RECORD WAS COMPLETED AND NO ANOMALIES WERE OBSERVED. A PACKAGING DEVIATION AUTHORIZATION WAS PERFORMED DURING MANUFACTURING OF THIS LOT NUMBER (LOT #L11647). THE PACKAGING DEVIATION AUTHORIZATION DOCUMENTED TO LABEL THE PRODUCT WITH 12 MONTH SHELF-LIFE AND STERILIZE PRODUCT WITHOUT INSTRUCTIONS FOR USE (IFU). PRIOR TO PRODUCT RELEASE 12-MONTH SHELF-LIFE TESTING WAS COMPLETED AND PASSED. IN ADDITION IFUS WERE PLACED IN EACH PRODUCT BOX PRIOR TO PRODUCT RELEASE. THE DEVIATION AUTHORIZATION HAS NO DIRECT IMPACT TO PRODUCT OR PRODUCT PERFORMANCE. ALL APPROPRIATE INSPECTIONS WERE COMPLETED. ON THE SUB-ASSEMBLY LEVEL PART #0918-04 (LOT #L11568) NO ANOMALIES WERE OBSERVED DURING DESTRUCTIVE TESTING. SPECIFICALLY 13 PARTS, AS PART OF PROCESS MONITORING, WERE TESTED FOR DISTAL JOINT TENSILE STRENGTH, ALL 13 PARTS MET THE ACCEPTANCE CRITERIA OF 0.75 LB MINIMUM. ALL VISUAL AND DIMENSIONAL INSPECTIONS WERE COMPLETED EITHER AT 100% INSPECTION OR A SAMPLE PLAN. THE DISTAL FLEXIBLE SHAFT WAS INSPECTED UNDER A SAMPLE PLAN PER (B)(4), ALL INSPECTED PARTS MET THE DIMENSIONAL REQUIREMENTS THEREFORE, NO ADDITIONAL INSPECTION WAS REQUIRED. THE PARTS MANUFACTURED IN THIS LOT MET THE REQUIRED CRITERIA AND ARE DEEMED ACCEPTABLE.

    Description of Event or Problem · 1

    THE CATHETER BROKE WHEN IT WAS BEING REMOVED FROM THE PACKAGING CARD. THE SITE WAS TRAINED TO REMOVE THE TABS BEFORE CATHETER REMOVAL BUT DID NOT DO THIS FOR THIS UNIT. THE FAILURE WAS OUTSIDE THE PATIENT AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F11647

    Patients

    Seq Age Sex Outcome Treatment
    1