BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 3128074 · Received May 23, 2013

    Report

    Report Number
    3005168196-2013-00175
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE SECOND CATHETER IS DAMAGED ON THE DISTAL END OF THE SHAFT. THIS DAMAGE IS APPROXIMATELY 0.5 CM AND 1.0 CM FROM THE DISTAL TIP OF THE CATHETER. THE MANDREL ADVANCED DISTALLY, BUT STOPPED ONCE IT APPROACHED THE DAMAGE AT THE DISTAL END OF THE SHAFT. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE DEVICES WERE EXAMINED AND IT WAS DETERMINED THAT NEITHER NEURON 053 CATHETER COULD PASS THROUGH THE CROSSCUT VALVE ON THE 6F ANSEL SHEATH BECAUSE THE DIAMETER OF THE PROXIMAL CROSSCUT VALVE ON THE ANSEL SHEATH IS TOO SMALL TO ACCEPT THE NEURON PEEL AWAY INTRODUCER SHEATH. USE OF THIS PEEL-AWAY INTRODUCER SHEATH IS REQUIRED TO AVOID DAMAGE TO THE NEURON TIP DURING INTRODUCTION THROUGH THE SHEATH DUE TO THE DISTAL FLEXIBLE DESIGN OF THE NEURON. TO CONFIRM THIS FINDING, A RIGID MANDREL WAS INSERTED INTO THE LUMEN OF THE RETURNED NEURONS TO PROVIDE SUPPORT. WITH THIS MANDREL INSERTED, BOTH OF THE RETURNED NEURONS PASSED COMPLETELY THROUGH THE CROSSCUT VALVE, AND SHAFT, OF THE ANSEL SHEATH. THE VALVE ON THE ANSEL SHEATH WAS THEN COMPARED TO OTHER SHEATHS WHERE COMPATIBILITY WITH NEURON HAS BEEN VERIFIED. IT WAS FOUND THAT IN OTHER SHEATHS, THE DIAMETER OF THE CROSSCUT VALVE IS USUALLY GREATER THAN 0.11 INCHES. THIS LARGE DIAMETER THEN TAPERS TO THE 6F (GREATER THAN 0.080") INNER DIAMETER OF THE SHAFT. THIS LARGER CROSSCUT VALVE DIAMETER IN OTHER SHEATHS ALLOWS THE INSERTION OF THE PEEL-AWAY NEURON INTRODUCER. ON THE ANSEL SHEATH, THE DIAMETER OF THE CROSSCUT VALVE IS AROUND 0.087", WHICH IS TOO SMALL FOR THE NEURON PEEL-AWAY INTRODUCER. COMPATIBILITY OF THE NEURON PEEL-AWAY INTRODUCER AND NEURON 053 CATHETER WITH TERUMO PINNACLE, COOK SHUTTLE, MERIT PRELUDE, CORDIS AVANTI, AND PENUMBRA NEURON MAX SHEATHS HAS BEEN CONFIRMED. THE COMPLAINT ALSO STATES THAT WHILE TRYING TO POSITION THE COIL IT DETACHED INSIDE OF THE PXSLIM CATHETER. ONLY THE COIL AND THE CATHETER WERE RETURNED FOR EVALUATION. HOWEVER, THE COIL IS BROKEN AND MISSING THE CONSTRAINT BALL. THE BREAK IN THE COIL SR WIRE INDICATES THAT THE COIL WAS UNDER A TENSILE FORCE GREATER THAN THE TENSILE STRENGTH OF THE MATERIAL. THE COIL WAS FURTHER DAMAGED DURING REMOVAL FROM THE CATHETER .THE CATHETER IS SLIGHTLY OVALIZED IN THE DISTAL PORTION OF THE SHAFT; THIS OVALIZATION MAY HAVE MADE IT DIFFICULT TO ADVANCE THE COIL. THERE IS NO PUSHER TO BE EVALUATED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00175 AND 3005168196-2013-00176.

    Description of Event or Problem · 1

    TWO NEURON 053 CATHETERS WOULD NOT GO INTO THE CROSSCUT VALVE OF THE 6 FR SHEATH. THE PHYSICIAN USED THE INTRODUCER, AND EVEN TRIED A 5.5 FR COOK PEEL AWAY INTRODUCER AND THE CATHETERS STILL WOULD NOT ADVANCE. LATER IN THE PROCEDURE, A PENUMBRA RUBY COIL DETACHED WHILE IN THE CATHETER. THE PHYSICIAN WAS TRYING TO POSITION THE RUBY COIL AND IT DETACHED IN THE PX-SLIM CATHETER. THE PHYSICIAN COULD NOT ADVANCE THE COIL ONCE IT WAS DETACHED, BUT WAS ABLE TO RETRIEVE THE COIL BY PULLING IT OUT WITH HIS HANDS. HE HAD TO STRETCH THE COIL DURING REMOVAL. CASE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT CATHETER AND ADDITIONAL COILS WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230190 NEURON DELIVERY CATHETER 053 DQY DQY PENUMBRA, INC. F27988

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR