BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PX SLIM DELIVERY MICROCATHETER

    MDR report key: 3911154 · Received July 2, 2014

    Report

    Report Number
    3005168196-2014-00440
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 6, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PX SLIM MICROCATHETER WAS OVALIZED APPROXIMATELY 3.5 CM FROM THE DISTAL TIP. THE OVALIZED AREA WAS APPROXIMATELY 1.0 CM IN LENGTH. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE COIL WAS REMOVED FROM THE PACKAGING HOOP BUT THE COIL SHEATH REMAINED INSIDE THE HOOP. THE COMPLAINT ALSO STATES THAT THE DISTAL TIP OF THE PXSLIM MICROCATHETER MIGHT HAVE BEEN OVALIZED BEEN DAMAGED BY ANOTHER CATHETER DURING THE PROCEDURE. EVALUATION OF THE RETURNED DEVICES CONFIRMED THAT THE COIL SHEATH DID NOT COME OUT OF THE HOOP WITH THE COIL AS INTENDED. THE COIL SHEATH IS PLACED ON THE DEVICE DURING MANUFACTURING AND IS DESIGNED TO STAY IN PLACE UNTIL THE COIL IS ADVANCED FROM THE SHEATH DURING USE. IT APPEARS THAT THE COIL WAS LOADED PROPERLY INTO THE SHEATH DURING MANUFACTURING HOWEVER, WHEN THE COIL WAS PULLED FROM THE HOOP, THE SHEATH WAS UNINTENTIONALLY PULLED FROM THE COIL. THIS IS EVIDENCED BY THE RETURN CONDITION OF THE COIL SHEATH. IF THE COIL SHEATH WERE NOT LOADED ONTO THE COIL PROPERLY DURING MANUFACTURING, THE SHEATH WOULD HAVE STAYED DEEP INSIDE THE HOOP. THE RETURNED HOOP HAD THE PROXIMAL END OF THE SHEATH PARTIALLY STICKING OUT OF THE HOOP, INDICATING THAT THE SHEATH WAS ATTACHED TO THE COIL BUT WAS UNATTACHED WHEN THE COIL WAS REMOVED. AN OVALIZATION IN THE DISTAL TIP OF THE PXSLIM MICROCATHETER WAS CONFIRMED. THE PHYSICIAN STATED THAT THIS MAY HAVE BEEN DUE TO THE GUIDE CATHETER IN USE. THE CAUSE OF THE DAMAGE IS UNKNOWN BUT MAY HAVE BEEN RELATED TO THE GUIDE CATHETER. THE PXSLIM MICROCATHETER WAS FUNCTIONAL PRIOR TO PLACEMENT OF THE THIRD COIL. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PACKAGING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00439.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INNER ILIAC ARTERY USING A PENUMBRA COIL 400 AND A PX SLIM DELIVERY MICROCATHETER. DURING THE PROCEDURE, AFTER DEPLOYING THE FIRST COIL, A PENUMBRA COIL 400 WAS REMOVED FROM ITS PACKAGE; HOWEVER, THE INTRODUCER SHEATH REMAINED INSIDE THE PACKAGE. THE PHYSICIAN USED AN INTRODUCER SHEATH FROM A PREVIOUS COIL TO PROCEED WITH THE PROCEDURE. UPON INSERTING THE THIRD COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THEREFORE, RETRIEVED THE COIL OUT OF THE PATIENT. ANOTHER MANUFACTURER'S DEVICE WAS INSERTED INTO THE PX SLIM DELIVERY MICROCATHETER AND RESISTANCE WAS FELT AT THE DISTAL LOCATION. THE PX SLIM WAS NOTED TO HAVE AN OVALIZED DISTAL DIP. THE PHYSICIAN USED ANOTHER PX SLIM TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385989 PX SLIM DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F41505

    Patients

    Seq Age Sex Outcome Treatment
    1