BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT GUIDECATHETER

    MDR report key: 7067575 · Received November 29, 2017

    Report

    Report Number
    2029214-2017-01311
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Report Date
    April 2, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K110055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDE CATHETER WAS RETURNED FOR ANALYSIS AND UPON VISUAL INSPECTION, NO DAMAGES OR ISSUES WERE FOUND WITH THE GUIDE CATHETER HUB, BODY OR DISTAL TIP. THE GUIDE CATHETER WAS FLUSHED AND WATER EXITED FROM THE DISTAL TIP. THE GUIDE CATHETER WAS THEN TESTED WITH AN IN-HOUSE MANDREL. NO ISSUES WERE ENCOUNTERED INSERTING THE IN-HOUSE MANDREL INTO THE GUIDE CATHETER HUB AND THROUGH THE DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER SEPARATION¿ COULD NOT BE CONFIRMED AND THE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE RETURNED GUIDE CATHETER EVALUATION DID NOT REVEAL ANY EVIDENCE THAT THE CATHETER WAS DEFECTIVE. THERE WAS NOT MALFUNCTION. THE PRODUCT ANALYSIS DOES NOT SUGGEST A POTENTIAL OR CONFIRMED MANUFACTURING ISSUE. IN ADDITION, ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. THEREFORE, MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. CORRESPONDENCE HAS BEEN SENT OUT FOR INFORMATION ON THE DEVICE; HOWEVER, NO RESPONSE HAS BEEN RECEIVED REGARDING THE STATUS OF THE DEVICE RETURN. A SUPPLEMENTAL REPORT WILL BE SENT ONCE WE RECEIVE THE DEVICE AND COMPLETE THE ANALYSIS OF THE DEVICE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT PIECES FROM INSIDE THE DISTAL SUPPORT CATHETER SHEARED OFF DURING A PROCEDURE. NO OTHER INFORMATION WAS PROVIDED FOR THIS EVENT. THE INFORMATION WAS REQUESTED, BUT WAS NOT RELEASED BY THE HOSPITAL. THE EVENT DATE AND ANCILLARY DEVICES(AND PREPARATION OF) WERE NOT PROVIDED AND ANY INFORMATION OTHER THAN RETURN OF THE DEVICE WAS NOT RELEASED BY THE HOSPITAL. THE DEVICE IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846408 SUPPORT GUIDECATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR RFX058-115-08 ASK-UNK

    Patients

    Seq Age Sex Outcome Treatment
    1