BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 3MAX

    MDR report key: 2883606 · Received December 21, 2012

    Report

    Report Number
    3005168196-2012-00436
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS CURRENTLY BEING RETAINED BY THE HOSPITAL HOWEVER; THEY HAVE STATED THAT THE DEVICE WILL BE MADE AVAILABLE FOR EVALUATION AFTER UNDERGOING AN INVESTIGATION AT THE HOSPITAL. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE DEVICE IS RETURNED AND THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE UNITS WERE RETURNED IN A PLASTIC BAG WHICH WAS IN A SEALED SPECIMEN BAG. THIS SPECIMEN BAG WAS INSIDE A VALLEY MEDICAL HOSPITAL BAG WHICH WAS INSIDE A LARGE BIOHAZARD BAG IN A FED EX SMALL BOX. THERE IS NO WAY TO IDENTIFY WHICH CATHETER IS ASSOCIATED WITH EACH OF THE PROVIDED LOT NUMBERS. THEREFORE, THIS INVESTIGATION WILL INCLUDE THE RESULTS AND CONCLUSIONS FOR BOTH CATHETERS. RESULTS: ONE CATHETER HAS DAMAGE IN THE DISTAL SHAFT PORTION. THE MARKERBAND IS MISSING FOR THE DISTAL TIP OF THE CATHETER. THE OTHER CATHETER ALSO HAS DAMAGE IN THE DISTAL SHAFT PORTION. THE MARKERBAND IS MISSING FOR THE DISTAL TIP OF THE CATHETER. THIS CATHETER ALSO HAD A SEPARATOR INSIDE THE LUMEN. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT MENTIONED THAT THE DISTAL TIP WAS SHEARED OFF ON BOTH OF THE 3MAX CATHETERS THAT WERE USED. THE COMPLAINT ALSO MENTIONS THAT THERE MAY HAVE BEEN A KINK IN THE NEURON MAX AT THE ARCH; THIS WAS LATER CONFIRMED IN A PICTURE TAKEN DURING ANGIOGRAPHY. IT IS UNKNOWN HOW THE NEURON MAX WAS KINKED HOWEVER; IT IS POSSIBLE THE DEVICE WAS KINKED DURING INSERTION INTO THE PATIENT. THE NEURON MAX CATHETER WAS THE ONLY ACCESS TOOL DURING THE PROCEDURE. AFTER EVALUATING THE RETURNED PRODUCT IT APPEARS THAT THE CATHETERS FAILED DUE TO EXCESSIVE TENSILE FORCE. THE VISUAL ANALYSIS SUGGESTS THAT EXCESSIVE FORCE WAS REQUIRED TO SHEAR THE MARKERBANDS FROM THE DISTAL TIPS OF THE CATHETER AS INDICATED BY THE DUCTILE ELONGATION OF THE DISTAL SHAFT AND THE DELAMINATION OF THE LINER FROM THE OUTER LAYER. THE MARKERBANDS CAN BE SHEARED FROM THE CATHETER TIPS WHEN SUBJECTED TO FORCES GREATER THAN THE SPECIFICATION. THIS FORCE WAS LIKELY APPLIED WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK ON THE CATHETER AGAINST THE RESISTANCE CREATED BY THE KINK IN THE TIP OF THE NEURON MAX CATHETER. THE TENSILE DATA FOR MARKERBAND ATTACHMENT WAS EVALUATED AGAINST THE LOTS BUILT IMMEDIATELY BEFORE AND AFTER LOT L26718. THE LOT NUMBER BEFORE WAS L26657 AND THE ONE AFTER WAS L27886. THE DATA IS SIMILAR FOR ALL THREE LOTS. LIKEWISE, THE TENSILE DATA FOR MARKERBAND ATTACHMENT WAS EVALUATED AGAINST THE LOTS BUILT IMMEDIATELY PRIOR AND AFTER LOT L27984. THE LOT NUMBER BEFORE WAS L27886 AND THE ONE AFTER WAS L28139. THE DATA POINTS FROM THESE LOTS ARE SIMILAR TO LOT L27984. THE MANUFACTURING RECORDS FOR THESE LOTS WERE REVIEWED AND REVEALED NO OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2012-00437 AND 3005168196-2013-00146.

    Description of Event or Problem · 1

    A PHYSICIAN WAS TREATING AN M2 SUPERIOR DIVISION STROKE WITH THE 3MAX REPERFUSION CATHETER SYSTEM. THE SYSTEM WAS ADVANCED PROXIMAL TO THE CLOT AND A 3MAX SEPARATOR WAS UTILIZED. AFTER SEVERAL MANIPULATIONS WITH THE SEPARATOR THE PHYSICIAN PULLED BACK THE ENTIRE SYSTEM AWAY FROM THE OCCLUSION THE DISTAL PORTION OF THE REPERFUSION CATHETER APPEARED TO HAVE SHEARED OFF. THE RADIOPAQUE TIP MARKER WAS VISABLE AND HAD POSITIONED ITSELF FURTHER DOWNSTREAM (TOWARD M3 SEGMENT). THE PHYSICIAN THEN DECIDED TO REMOVE ANOTHER 3MAX CATHETER FROM INVENTORY SINCE THE VESSEL WAS NOT COMPLETELY OPENED. AS THE PHYSICIAN ADVANCED THE NEW 3MAX CATHETER TOWARD THE OCCLUSION IT WAS OBSERVED THE DISTAL TIP ALSO SHEARED OFF AND LODGED INTO THE SAME AREA AS THE FIRST TIP. NO SEPARATOR WAS USED WITH THE SECOND CATHETER. IT IS UNCLEAR FROM THE REPORTS OF THE INCIDENT IF THE MARKER BAND CAME OFF THE CATHETER OR THE ENTIRE TIP SHEARED OFF. WE ARE WAITING TO RECEIVE THE PRODUCT BACK FROM THE HOSPITAL ONCE THEY COMPLETE THEIR INVESTIGATION. AFTER SPEAKING WITH THE PHYSICIAN HE INDICATED THAT THERE MIGHT HAVE BEEN A KINK IN THE NEURON MAX AT THE ARCH WHICH WAS THEIR ONLY ACCESS TOOL DURING THE PROCEDURE. THE ACCOUNT DID NOT HAVE THE NEURON MAX FOR OUR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 3MAX NRY NRY PENUMBRA, INC. F26718

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other