BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL Q6-69145

    MDR report key: 8740940 · Received June 27, 2019

    Report

    Report Number
    3011410509-2019-00002
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 25, 2019
    Report Date
    June 20, 2019
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Product Code
    DQY
    UDI-DI
    B293Q6691450
    PMA / PMN Number
    K163233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED Q6 DEVICE WAS RECEIVED IN TWO (2) SEPARATE PIECES FULLY TRACEABLE WITH MIVI LOT NUMBER. NO ADDITIONAL COMPONENTS WERE RECEIVED FOR ANALYSIS. DISTAL SHAFT APPEARED NORMAL, DISTAL END NOT DAMAGED, PROXIMAL EDGE (WHERE CATHETER SEGMENT AND PUSH WIRE ATTACH) WAS SPLIT AND DISPLAYED PHYSICAL DAMAGE. BASED ON DEVICE ANALYSIS AND TYPE OF DAMAGE, THE MOST LIKELY SCENARIO FOR THE PUSH WIRE DETACHMENT IS THAT THE PROXIMAL EDGE OF THE Q6 TUBULAR SEGMENT EITHER INTERACTED WITH JUST THE DISTAL TIP OF THE GUIDE CATHETER OR WITH THE DISTAL TIP OF THE GUIDE CATHETER IN CONJUNCTION WITH A GUIDEWIRE. THIS INTERACTION CAUSED DAMAGE RESULTING IN A SEPARATION OF THE PUSH WIRE FROM THE TUBULAR SEGMENT. THE TYPE OF DAMAGE IS INDICATIVE OF THE DEVICE BEING RETRACTED WHILE EXPERIENCING EXCESSIVE RESISTANCE. ACCESSORY DEVICES WERE NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORDS FOR THE DEVICE LOT DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY RECORDS ISSUES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STROKE PROCEDURE THE Q CATHETER WAS USED BUT COMPLETE REVASCULARIZATION WAS NOT ACHIEVED. THE Q CATHETER WAS REINTRODUCED INTO THE VASCULATURE, UPON RETRACTION RESISTANCE WAS FELT. THE CATHETER WAS FORCIBLE RETRACTED AND SEPARATED INTO TWO PIECES WITH ONE PIECE REMAINING IN THE PATIENTS BODY. ATTEMPTS MADE TO SNARE THE PIECE WERE UNSUCCESSFUL. DETACHED SEGMENT WAS SUCCESSFULLY RETRIEVED DURING CAROTID ENDARTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533131 MODEL Q6-69145 Q6 DISTAL ACCESS CATHETER DQY MIVI NEUROSCIENCE, INC. Q6-69145 M19010002 B293Q6691450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention