BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU

    MDR report key: 23367678 · Received October 23, 2025

    Report

    Report Number
    1319211-2025-00042
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 6, 2025
    Report Date
    April 1, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    UDI-DI
    H787107332010
    PMA / PMN Number
    K112452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF THE CATHETER TIP DETACHED WAS CONFIRMED. THE FRACTURE LOCATION WAS AT THE WELD JUNCTION TO THE CATHETER SHAFT AND THERE IS CLEAR MECHANICAL (STRETCHING) DAMAGE AT THIS LOCATION. IN ADDITION, THE TIP TUBING MATERIAL WAS ACCORDIONED. THE ROOT CAUSE FOR THIS TIP DETACHMENT IS HANDLING DAMAGE DURING DEVICE USE; PARTICULARLY USING THIS ANGIOGRAPHIC CATHETER DEVICE DURING THE PTA CROSSOVER PROCEDURE. PER DEVICE DFU THE INTENDED USE OF AN ANGIOGRAPHIC CATHETER IS: ANGIOGRAPHIC CATHETERS ARE SINGLE-USE INVASIVE MEDICAL DEVICES WHICH ARE INTENDED TO BE USED FOR PATIENTS IN NEED OF ANGIOGRAPHIC DIAGNOSIS. THE CATHETER IS INSERTED INTO THE VASCULATURE SYSTEM AND GUIDED TO THE TARGET ANATOMICAL LOCATION. THE PRIMARY FUNCTION OF ANGIODYNAMICS ANGIOGRAPHIC CATHETERS IS TO DELIVER CONTRAST MEDIA TO A SPECIFIED ANATOMICAL LOCATION FOR SUBSEQUENT DIAGNOSIS OR INTERVENTION. A REVIEW OF THE ANGIODYNAMICS' DEVICE HISTORY RECORDS (DHR) WAS PERFORMED FOR THE INDICATED PACKAGING LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL RECEIVING, STERILIZATION AND DISTRIBUTION SPECIFICATIONS; I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. LABELING REVIEW: INSTRUCTIONS FOR USE 16900444-01 IS PROVIDED WITH THIS CATHETER DEVICE AND CONTAINS THE FOLLOWING STATEMENTS. INTENDED USE: ANGIOGRAPHIC CATHETERS ARE SINGLE-USE INVASIVE MEDICAL DEVICES WHICH ARE INTENDED TO BE USED FOR PATIENTS IN NEED OF ANGIOGRAPHIC DIAGNOSIS. THE CATHETER IS INSERTED INTO THE VASCULATURE SYSTEM AND GUIDED TO THE TARGET ANATOMICAL LOCATION. THE PRIMARY FUNCTION OF ANGIODYNAMICS ANGIOGRAPHIC CATHETERS IS TO DELIVER CONTRAST MEDIA TO A SPECIFIED ANATOMICAL LOCATION FOR SUBSEQUENT DIAGNOSIS OR INTERVENTION. WARNINGS: NEVER ADVANCE OR RETRACT AN ANGIOGRAPHIC CATHETER OR GUIDEWIRE AGAINST RESISTANCE. THIS MAY RESULT IN DAMAGE TO THE VESSEL, THE PRODUCT, OR BOTH. 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

    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).

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOFT-VU RIM 4F X 65CM 035 B 0SH. DURING A PTA CROSSOVER FROM RIGHT TO LEFT PROCEDURE, THE TIP OF THE CATHETER DETACHED INSIDE OF THE PATIENT. A COOK 180CM AMPLATZ WIRE WAS BEING USED AT THE TIME. THE TIP WAS REMOVED USING ANOTHER INSTRUMENT. THE PROCEDURE WAS THEN COMPLETED WITH A NEW OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515470 SOFT-VU SOFT-VU ANGIOGRAPHIC CATHETER, RIM, BRAIDED DQO ANGIODYNAMICS, INC. 10733201 A1425059 H787107332010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown