BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR FLEX 041

    MDR report key: 1860446 · Received September 27, 2010

    Report

    Report Number
    3005168196-2010-00644
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 5, 2010
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K100769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: PRIOR TO THE DECONTAMINATION DAMAGE, THE SEPARATOR AND TORQUE DEVICE WERE FULLY FUNCTIONAL. METHOD CODE: IN ORDER TO UNDERSTAND THE COMPLAINT, A PSF041, PSF032, AND PSS041 WERE USED TO REPLICATE THE EVENT. A TORQUE DEVICE WAS PLACED ON THE PROXIMAL END OF EACH OF THE SEPARATOR FLEX WIRES DISTAL TO THE END OF THE SHRINK TUBING AND TIGHTENED. THEN THE TORQUE DEVICE WAS LOOSENED AND AN ATTEMPT WAS MADE TO REMOVE IT FROM THE PROXIMAL END OF THE SEPARATOR. THE TORQUE DEVICE WOULD NOT PASS THE DISTAL EDGE OF THE SHRINK TUBING AND WOULD CONTINUALLY GET STUCK. IF PULLED QUICKLY FROM THE PROXIMAL END OF THE SEPARATOR, THE TORQUE DEVICE MAY PASS THE SHRINK TUBING BUT IT WOULD SCRAPE THE MATERIAL AS IT WENT OVER. THIS EXERCISE WAS PERFORMED WITH THE STAINLESS STEEL SEPARATOR AND YIELDED SIMILAR RESULTS. THE PROXIMAL SECTION OF THE SEPARATOR IS APPROX 25 CM IN LENGTH. THE SHRINK TUBING MARKER BAND IS CRUMPLED AT THE PROXIMAL END. CONCLUSION: THE COMPLAINT DESCRIPTION DOES NOT IDENTIFY A CLEAR REASON WHY THE PHYSICIAN WOULD CHOOSE TO REMOVE THE TORQUE DEVICE AFTER PLACING IT ON THE SEPARATOR. FOLLOW UP INFO SUGGESTS THAT THIS IS SIMPLY A SPECIFIC TECHNIQUE THAT IS NOT COMMONLY USED IN CLINICAL PRACTICE. THE TORQUE DEVICE WAS NOT DESIGNED TO BE REMOVED FROM THE SEPARATOR ONCE IT IS PLACED AND IS NOT A NECESSARY FEATURE IN THE CLINICAL SETTING. DIFFICULTY REMOVING THE TORQUE DEVICE IN NO WAY IMPAIRS THE FUNCTION OF 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 PHYSICIAN ATTEMPTED TO REMOVE THE TORQUING DEVICE ON THREE DIFFERENT FLEX SEPARATORS. THE TORQUE DEVICE WOULD NOT COME OFF ANY OF THE SEPARATORS. THE TORQUE DEVICE APPEARED TO GET HUNG UP AT THE DISTAL POINT OF THE PROXIMAL COLOR BAND/SHRINK WRAP. TWO OF THE TORQUE DEVICES WERE BROKEN TO REMOVE FROM THE FLEX WIRE WHILE THE THIRD REMAINED ON THE DEVICE. IT APPEARED TO THE PHYSICIAN THAT THE TORQUE DEVICE GOT HUNG UP ON THE COLOR BAND UPON REMOVAL. NO ISSUES PRESENTED THEMSELVES WHEN PUTTING THE TORQUE DEVICE ON THE SEPARATOR FLEX. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00643 AND MDR 3005168196-2010-00645.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR FLEX 041 PERCUTANEOUS CATHETER NRY PENUMBRA INC. F17020

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR