BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 026

    MDR report key: 1873456 · Received September 17, 2010

    Report

    Report Number
    3005168196-2010-00632
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    April 2, 2009
    Report Date
    April 6, 2009
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE RETURN CONTAINER INCLUDED THE ORIGINAL STERILE POUCHES FOR ALL THE LISTED ITEMS PLUS AN ADDITIONAL POUCH FOR AN 026 SEPARATOR. IT WAS NOT CLEAR WHICH LOT NUMBER WENT WITH WHICH DEVICE. EACH ITEM WAS SOAKED IN AND FLUSHED WITH 1:10 DILUTION OF HOUSEHOLD BLEACH. THE FIRST SEPARATOR EVALUATED WAS BROKEN INTO 2 PIECES WITH THE LONGEST PIECE LODGED INSIDE THE BLOOD FILLED CATHETER. THE SECOND PIECE SHOWS A 90 DEGREE BEND AT THE FIRST TAPER GRIND AND A BREAK ABOUT 1.5 CM INTO THE COATED REGION. THE INCIDENT REPORT SAYS THAT THE SEPARATOR WAS NEVER COMPLETELY INTRODUCED INTO THE REPERFUSION CATHETER AND THE "WIRE LOOKED SLIGHTLY BENT PRIOR TO DEPLOYMENT." IT IS UNCLEAR IF THE BEND WE OBSERVE HERE IS THE BEND DISCUSSED. THE TWO OTHER SEPARATORS WERE BROKEN OFF INSIDE BLOOD FILLED CATHETERS. THE PROXIMAL "HANDLE" PORTION SHOWS A BREAK ABOUT 0.8 CM INTO THE PROXIMAL COATING REGION. THE INCIDENT REPORT IDENTIFIES THE PHYSICIAN TECHNIQUE WAS USING LONG STROKES TO MANIPULATE THE SEPARATOR WIRE. THE DAMAGE TO THE SEPARATOR WIRE IS CONSISTENT WITH THE COATING JUNCTION BEING MANIPULATED OUTSIDE THE RHV. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN USED THREE SEPARATORS AND REPERFUSION CATHETERS, ONE PENUMBRA SYS 032 AND TWO PENUMBRA SYS 026. THE FIRST SEPARATOR WAS PUT IN THE REPERFUSION CATHETER WITH DIFFICULTY (WIRE LOOKED SLIGHTLY BENT PRIOR TO DEPLOYMENT), AND WIRE WOULD NEVER COMPLETELY GO THROUGH THE REPERFUSION CATHETER. THE SECOND 026 SEPARATOR DEPLOYED PERFECTLY AND THE PHYSICIAN BEGAN SUCTION AND USED THE SEPARATOR. THE SEPARATOR BROKE AT THE SILVER TO GREEN TRANSITION AFTER PHYSICIAN USED LONG STROKES. HE BROKE A THIRD DOING SAME THING. AFTER FURTHER DISCUSSION WITH THE PHYSICIAN, HE WAS INSTRUCTED THAT THE TRANSITION SHOULD STAY HOUSED IN THE RHV AND THAT LONG SEPARATOR MOVEMENT COULD CAUSE THE SEPARATOR WIRE TO KINK OR BREAK IF MANIPULATED OUTSIDE THE RHV. THIS MDR IS ASSOCIATED WITH MDR3005168196-2010-00315 AND MDR3005168196-2010-00633.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 026 PERCUTANEOUS CATHETER NRY PENUMBRA INC. F14138

    Patients

    Seq Age Sex Outcome Treatment
    1