BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1644692 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00146
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: VISUAL: THE CATHETER WAS KINKED 3 CM FROM THE DISTAL TIP. CONCLUSION: BASED ON THE REPORT FROM THE PHYSICIAN, THE CATHETER WAS LIKELY KINKED DURING ASSEMBLY OR PACKAGING. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO FDA WARNING LETTER DATED DECEMBER 31, 2009. A REVIEW OF THE DESIGN HISTORY RECORD WAS COMPLETED AND REQUIRED INSPECTIONS WERE COMPLETED. A VISUAL INSPECTION WAS COMPLETED AT 100%, 5 PARTS WERE INITIALLY INSPECTED AS FAILURE FOR SEPARATED TRANSITION (ST), THEN CORRECTED TO PASS WITHOUT JUSTIFICATION. AFTER DISCUSSION WITH INSPECTOR, THE INSPECTOR REMEMBERED THAT HE WAS INFORMED BY A SENIOR INSPECTOR (I.E. TRAINER) THAT WHAT HE INITIALLY MARKED AS FAILURE FOR SEPARATED TRANSITION WAS NOT REALLY A SEPARATED TRANSITION, THEREFORE, A REVIEW OF THE PARTS WAS COMPLETED AND CORRECTIONS WERE MADE TO THE INSPECTION RECORD. THE INSPECTOR WAS NOTIFIED THAT JUSTIFICATION WILL BE REQUIRED ON CORRECTIONS FROM FAILURE TO PASS OR VISE VERSA. ALSO ASSOCIATED WITH THIS LOT, 14 UNITS WERE RE-PROCESSED FOR PACKAGING DAMAGE (B) (4) POST ORIGINAL STERILIZATION. PRIOR TO RE-PROCESSING, THE PRODUCT WAS RE-INSPECTED FOR DAMAGE, NO DAMAGE WAS FOUND, THEREFORE, THE PRODUCT WAS REPACKAGED, INSPECTED, AND STERILIZED. NO OTHER ANOMALIES WERE FOUND WITH THIS LOT. ALL APPROPRIATE INSPECTIONS WERE COMPLETED AND ALL PARTS ARE DEEMED ACCEPTABLE AND SAFE. SUB-ASSEMBLY: PART # 0918-04; LOT # L11993. ON THE SUB-ASSEMBLY LEVEL PART # 0918-04 (LOT # L11993) NO ANOMALIES WERE OBSERVED DURING VISUAL AND DIMENSIONAL INSPECTIONS. ALL INSPECTIONS WERE COMPLETED EITHER AT 100% INSPECTION OR AT A SAMPLE PLAN, PER PROCESS MONITORING. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER PROCESS MONITORING CRITERIA AND MET THE REQUIRED SPECIFICATION. THE PARTS MANUFACTURED IN THIS LOT MED THE REQUIRED CRITERIA AND ARE DEEMED ACCEPTABLE.

    Description of Event or Problem · 1

    UPON REMOVING THE NEURON FROM THE PACKAGING, KINK IN THE DISTAL TIP OF THE CATHETER WAS NOTICED. THE PHYSICIAN REMOVED THE CATHETER FROM THE TABLE AND TOOK ANOTHER NEURON FROM THEIR INVENTORY. THE PROCEDURE WENT WELL WITH NO PT ADVERSE EVENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F12211

    Patients

    Seq Age Sex Outcome Treatment
    1