BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 5578813 · Received April 14, 2016

    Report

    Report Number
    3005168196-2016-00493
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    March 17, 2016
    Report Date
    March 17, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012179
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) DISTAL TIP SHOWED SIGNS OF COMPRESSION AND BUCKLING, SUGGESTING THAT THE TIP FOLDED OVER ITSELF DURING USE. THE DISTAL TIP OF THE NEURON MAX WAS OVALIZED. THE NEURON MAX MARKER BAND WAS NOT PRESENT IN ITS ORIGINAL LOCATION. THE NEURON MAX DISTAL TIP WAS CUT LONGITUDINALLY BY THE PENUMBRA INVESTIGATOR TO ALLOW FOR FURTHER EVALUATION. THE MARKER BAND IMPRINT WAS SLIGHTLY DISTAL TO THE BRAIDED SHAFT. THE DISTAL TIP OF THE NEURON MAX WAS PEELED BACK BY THE PENUMBRA INVESTIGATOR TO ALLOW FOR FURTHER EVALUATION. THE LAMINATION IMPRINT OF THE MARKER BAND WAS VISIBLE AND APPARENT. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED SIGNS OF DISTAL TIP BUCKLING AND COMPRESSION THAT ARE CONSISTENT WITH THE TIP FOLDING OVER ITSELF DURING USE. IN ADDITION, THE DISTAL END OF THE NEURON MAX SHOWED SIGNS OF OVALIZATION. THESE FINDINGS LIKELY RESULTED FROM THE ATTEMPTS TO INSERT THE NEURON MAX INTO THE PATIENT. AS REPORTED IN THE ORIGINAL COMPLAINT, THE PHYSICIAN DID NOT DILATE THE PATIENT VESSEL, AND ROTATED THE NEURON MAX DURING INSERTION. DURING THIS PROCESS, IT IS LIKELY THAT THE NEURON MAX TIP WAS WEAKENED AND COMPRESSED AGAINST THE PATIENT¿S ANATOMY. IN ADDITION, BECAUSE THE NEURON MAX HAS A HYDROPHILIC COATING AT THE DISTAL TIP, IT IS LIKELY THAT THE PHYSICIAN GRIPPED THE TIP OF THE NEURON MAX FIRMLY TO OVERCOME THE DEVICE LUBRICITY DURING THE ATTEMPTED INSERTIONS INTO THE PATIENT ANATOMY. THIS MAY HAVE CAUSED OVALIZATION ON THE DISTAL END OF THE CATHETER SHAFT AT THE LOCATION OF THE MARKER BAND WHICH WOULD LIKELY WEAKEN THE DISTAL TIP OF THE NEURON MAX FURTHER. FURTHER EVALUATION REVEALED THAT THE MARKER BAND IMPRINT WAS SLIGHTLY DISTAL TO THE DISTAL END OF THE BRAIDED SHAFT. THIS FINDING WAS DETERMINED NOT TO BE THE ROOT CAUSE FOR THIS COMPLAINT. 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 PATIENT WAS UNDERGOING A PIPELINE EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) FOR A PREVIOUSLY CLIPPED ANEURYSM USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE NEURON MAX WAS USED AS THE PRIMARY CATHETER. THE PHYSICIAN DID NOT DILATE THE FEMORAL AREA BEFORE INSERTING THE NEURON MAX AND STATED THAT HE WAS ROTATING THE NEURON MAX AS HE WAS INSERTING IT INTO THE FEMORAL ARTERY. THE PHYSICIAN ALSO STATED THAT NO RESISTANCE WAS FELT AT ANY POINT AND THAT THERE MAY HAVE BEEN SOME SCAR TISSUE AT THE GROIN. THE NEURON MAX WAS DIRECTLY TAKEN UP OVER THE DILATOR TO THE CAROTID ARTERY. THE PHYSICIAN THEN USED ANOTHER MANUFACTURER'S SUPPORT CATHETER INSIDE THE NEURON MAX AND NAVIGATED TO THE CERVICAL INTERNAL CAROTID ARTERY (ICA). NEXT, ANOTHER MANUFACTURER'S DEVICE WAS TRACKED TO THE ANEURYSM USING A GUIDE WIRE. AT THIS POINT, THE PHYSICIAN NOTICED WHAT HE BELIEVED TO BE A SURGICAL CLIP, MOVING, AS HE WAS ADVANCING THE CATHETER. THE PHYSICIAN THEN REALIZED THAT THE "SURGICAL CLIP" WAS ACTUALLY THE PLATINUM MARKER BAND OF THE NEURON MAX THAT HAD DISCONNECTED FROM THE TIP OF THE NEURON MAX. THEREFORE, THE PHYSICIAN REMOVED THE OTHER MANUFACTURERS'' DEVICES FROM THE PATIENT, KEEPING THE NEURON MAX IN PLACE AND THEN ATTEMPTED MANUAL ASPIRATION USING A PENUMBRA SYSTEM ACE REPERFUSION CATHETER. WHILE ASPIRATING, THE PHYSICIAN NOTICED THAT THE NEURON MAX MARKER BAND WAS GOING MORE DISTALLY AND THEREFORE, ATTEMPTED TO RETRIEVE IT USING ANOTHER MANUFACTURER'S SNARE DEVICE. AFTER A FAILED ATTEMPT TO RETRIEVE THE MARKER BAND USING THE SNARE DEVICE, THE PHYSICIAN SUCCESSFULLY RETRIEVED IT USING ANOTHER MANUFACTURER'S RETRIEVAL DEVICE. THE PROCEDURE WAS CANCELLED AT THIS POINT AND A FOLLOW-UP CT SCAN WAS PERFORMED. THE PATIENT'S CONDITION WAS STABLE AND THE RESULTS OF THE CT SCAN CAME BACK NORMAL. THEREFORE, THE PATIENT WAS DISCHARGED THE NEXT DAY AND WAS SCHEDULED TO RETURN IN TWO WEEKS TO COMPLETE THE PIPELINE INTERVENTION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231493 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. F66827 00814548012179

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention