BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Q6 ASPIRATION CATHETER

    MDR report key: 8506116 · Received April 11, 2019

    Report

    Report Number
    3011410509-2019-00001
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    February 20, 2019
    Report Date
    April 11, 2019
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED IN TWO PIECES. UPON VISUAL INSPECTION, DEVICE WAS SEPARATED AT THE PROXIMAL EDGE OF THE CATHETER AT THE ATTACHMENT BETWEEN THE CATHETER AND THE PUSH WIRE. THE PROXIMAL EDGE OF THE CATHETER DISPLAYED PHYSICAL DAMAGE WHERE THE PUSH WIRE WAS ATTACHED. THIS TYPE OF DAMAGE CAN OCCUR AS A RESULT OF FORCEFULLY RETRACTING THE Q CATHETER AGAINST RESISTANCE. IT IS POSSIBLE THE Q6 CATHETER INTERACTED WITH THE SHEATH WHILE ATTEMPTING TO FORCIBLY RETRACT IT AND THE DEVICE SEPARATED. ACCESSORY DEVICES WERE NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORDS FOR THE DEVICE LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY RECORDS. THIS DEVICE IS A CE MARKED DEVICE DISTRIBUTED ONLY IN THE EU.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING THE Q6 ASPIRATION CATHETER (Q6-69145-E). DURING THE PROCEDURE THE PHYSICIAN NOTICED THE PROXIMAL MARKER BAND OF THE Q CATHETER HAD BEEN EXTENDED PAST THE DISTAL MARKER BAND OF THE GUIDE CATHETER. THE PHYSICIAN ATTEMPTED TO RETRACT THE Q6 INTO THE GUIDE CATHETER BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE Q6 AND THE CATHETER TOGETHER THROUGH THE SHEATH. DURING THE REMOVAL, THE Q6 CATHETER SEPARATED WITH THE WIRE PORTION IN THE SHEATH. THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE DETACHED CATHETER PORTION OF THE Q6. THE THROMBECTOMY PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299614 Q6 ASPIRATION CATHETER Q6 ASPIRATION CATHETER DQY MIVI NEUROSCIENCE, INC. Q6-69145-E M18120007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention