BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU

    MDR report key: 20407413 · Received October 9, 2024

    Report

    Report Number
    1319211-2024-00066
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    April 1, 2024
    Report Date
    October 28, 2024
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    UDI-DI
    H787107322010
    PMA / PMN Number
    K112452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF ANGIOGRAPHIC CATHETER TIP DETACHED DURING THE PROCEDURE COULD NOT BE CONFIRMED AS NO COMPLAINT SAMPLE WAS RETURNED. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. DEVICE HISTORY RECORD REVIEW OF THE PACKAGING/ASSEMBLY SHR LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. LABELING REVIEW: INSTRUCTIONS FOR USE 16900444-01 IS PROVIDED WITH THIS CATHETER DEVICE AND CONTAINS THE FOLLOWING STATEMENTS. WARRANTY ANGIODYNAMICS, INC. WARRANTS THAT REASONABLE CARE HAS BEEN USED IN THE DESIGN AND MANUFACTURE OF THIS INSTRUMENT. THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH HEREIN, WHETHER EXPRESS OR IMPLIED BY OPERATION OF LAW OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. HANDLING, STORAGE, CLEANING AND STERILIZATION OF THIS INSTRUMENT AS WELL AS OTHER FACTORS RELATING TO THE PATIENT, DIAGNOSIS, TREATMENT, SURGICAL PROCEDURES AND OTHER MATTERS BEYOND ANGIODYNAMICS, INC.'S CONTROL DIRECTLY AFFECT THE INSTRUMENT AND THE RESULTS OBTAINED FROM ITS USE. ANGIODYNAMICS, INC.'S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT OF THIS INSTRUMENT AND ANGIODYNAMICS, INC. SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSSES, DAMAGES OR EXPENSES DIRECTLY OR INDIRECTLY ARISING FROM THE USE OF THIS INSTRUMENT. ANGIODYNAMICS, INC. NEITHER ASSUMES, NOR AUTHORIZES ANY OTHER PERSON TO ASSUME FOR IT, ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THIS INSTRUMENT. ANGIODYNAMICS, INC. ASSUMES NO LIABILITY WITH RESPECT TO INSTRUMENTS REUSED, REPROCESSED OR RESTERILIZE, MODIFIED OR ALTERED IN ANY WAY, AND MAKES NO WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO SUCH INSTRUMENTS. CONTENTS SUPPLIED STERILE USING AN ETHYLENE OXIDE (EO) PROCESS. DO NOT USE IF STERILE BARRIER IS DAMAGED. IF DAMAGE IS FOUND, CALL YOUR ANGIODYNAMICS, INC. REPRESENTATIVE. INSPECT PRIOR TO USE TO VERIFY THAT NO DAMAGE HAS OCCURRED IN SHIPPING. DO NOT USE IF PACKAGE IS DAMAGED. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Description of Event or Problem · 0

    AN END USER REPORTED AN ISSUE WITH A SOFT-VU OF 5F X 65CM 035 NB 6SH. THE RADIO-OPAQUE DISTAL TIP OF THE CATHETER DETACHED FROM THE REST OF THE CATHETER DURING MID PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728455 SOFT-VU CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO ANGIODYNAMICS 10732201 H787107322010

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male