BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 5900985 · Received August 24, 2016

    Report

    Report Number
    3005168196-2016-01212
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    July 25, 2016
    Report Date
    July 25, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012490
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) WAS STRETCHED FROM APPROXIMATELY 122.0 CM FROM THE HUB. THE STRETCHED SEGMENT OF THE CATHETER SHAFT WAS APPROXIMATELY 53.0 CM LONG. CONCLUSION: EVALUATION OF THE RETURNED 3MAX CONFIRMED IT WAS STRETCHED. IT IS POSSIBLE FOR THE DISTAL SEGMENT OF THE 3MAX TO BECOME RESTRAINED AGAINST PATIENT ANATOMY OR OTHER DEVICES USED IN THE PROCEDURE THAT MAY HAVE PROLAPSED IN THE PATIENT ANATOMY. IF THE DISTAL SEGMENT OF 3MAX IS PINNED OR OTHERWISE RESTRAINED, AND THEN FORCEFULLY WITHDRAWN AGAINST THE RESISTANCE, THE CATHETER SHAFT MAY BECOME STRETCHED. SINCE THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE OF THE RESISTANCE EXPERIENCED BY THE PHYSICIAN COULD NOT BE DETERMINED. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) WAS STRETCHED FROM APPROXIMATELY 122.0 CM FROM THE HUB. THE STRETCHED SEGMENT OF THE CATHETER SHAFT WAS APPROXIMATELY 53.0 CM LONG. EVALUATION OF THE RETURNED 3MAX CONFIRMED IT WAS STRETCHED. IT IS POSSIBLE FOR THE DISTAL SEGMENT OF THE 3MAX TO BECOME RESTRAINED AGAINST PATIENT ANATOMY OR OTHER DEVICES USED IN THE PROCEDURE THAT MAY HAVE PROLAPSED IN THE PATIENT ANATOMY. IF THE DISTAL SEGMENT OF 3MAX IS PINNED OR OTHERWISE RESTRAINED, AND THEN FORCEFULLY WITHDRAWN AGAINST THE RESISTANCE, THE CATHETER SHAFT MAY BECOME STRETCHED. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. 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 THROMBECTOMY PROCEDURE IN THE M1 SECTION OF THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 3 MAX REPERFUSION CATHETER (3MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) TO THE TARGET VESSEL VIA THE 3MAX AND ASPIRATED THROMBUS USING THE ACE 64. THE PHYSICIAN THEN DECIDED TO ADVANCE A PRESET STENT RETRIEVER TO THE TARGET VESSEL THROUGH THE 3MAX IN ORDER TO REMOVE THE FINAL PART OF THE THROMBUS. HOWEVER, AFTER INSERTING THE PRESET STENT AND WHILE RETRACTING THE 3MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE 3MAX BECAME STRETCHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY APPLYING THE SOLUMBRA TECHNIQUE USING THE STENT RETRIEVER AND THE ACE64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553671 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F69086 00814548012490

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR