BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU SIZING ANGIOGRAPHIC CATHETER

    MDR report key: 17565765 · Received August 17, 2023

    Report

    Report Number
    1319211-2023-00044
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 22, 2023
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    PMA / PMN Number
    K112452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION.THE CUSTOMER'S REPORTED COMPLAINT OF ANGIOGRAPHIC CATHETER TIP DETACHED DURING PROCEDURE USE COULD NOT BE CONFIRMED AS NO COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE CUSTOMER DID NOT PROVIDE ANY PHOTOS OF THE DAMAGED PRODUCT. WITHOUT RECEIVING A SAMPLE FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS; I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE LABELING REVIEW: INSTRUCTIONS FOR USE 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).

    Description of Event or Problem · 0

    THE SOFT-VU OF 5F X 65CM 038 NB 6SH CATHETER WAS EXAMINED AND WAS INTACT PRIOR TO USE. DURING THE PROCEDURE, THE TIP OF THE CATHETER BROKE OFF IN THE PATIENT'S BLOOD VESSEL. THE CATHETER TIP WAS RETRIEVED BY THE PHYSICIAN USING A SNARE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198483 SOFT-VU SIZING ANGIOGRAPHIC CATHETER SOFT-VU SIZING ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS 5785472

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown