BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAXCESS 14 GUIDEWIRE (14 IN.)

    MDR report key: 13488164 · Received February 8, 2022

    Report

    Report Number
    2032493-2022-00052
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    November 26, 2021
    Report Date
    January 14, 2022
    Manufacturer
    MICROVENTION, INC
    Product Code
    MOF
    UDI-DI
    00810170014864
    PMA / PMN Number
    K133725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL ISSUE A SUPPLEMENTAL MDR REPORT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED TRAXCESS DEVICE DID NOT FIND ANY CONDITION CONSISTENT WITH THE HYDROPHILIC COATING ISSUE DESCRIBED IN THE REPORTED EVENT. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION CONFIRMED THAT THERE WAS NOT ANY INDICATION OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE DEVICE PREPARATION PRIOR TO USE, THE HYDROPHILIC COATING WAS OBSERVED TO BE PEELING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903540 TRAXCESS 14 GUIDEWIRE (14 IN.) CATHETER, GUIDE WIRE MOF MICROVENTION, INC GW1420040X 210121 00810170014864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown