BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT-VU SIZING ANGIOGRAPHIC CATHETER

    MDR report key: 7734953 · Received July 31, 2018

    Report

    Report Number
    1319211-2018-00072
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 3, 2018
    Report Date
    November 13, 2018
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    DQO
    UDI-DI
    H787107195035
    PMA / PMN Number
    K112452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED FOR EVALUATION WAS A SOFT-VU CATHETER. A VISUAL REVIEW OF THE CATHETER NOTED A FRACTURE ON THE TIP. DUE TO DAMAGE TO THE CATHETER TIP DIMENSIONS COULD NOT BE PERFORMED. THE FRACTURE OCCURS 2.5MM OF THE WELD JOINT, ON THE SOFT TIP. THE FRACTURED OFF PIECE MEASURES 6.8CM. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF SOFT-VU TIP FRACTURE IS CONFIRMED. A CAPA WAS INITIATED TO DETERMINE THE ROOT CAUSE AND IMPLEMENT A CORRECTIVE / PREVENTATIVE ACTION FOR THIS TYPE FAILURE. THE COMPLAINT SAMPLE (ITEM 14400102 LOT 4993034) WAS MANUFACTURED BEFORE THE DESIGN CHANGE PER THE CAPA (B)(4) (AUGUST 11, 2017). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, CONTAINS A STATEMENT; "RESHAPING OF CATHETER TIP IS NOT RECOMMENDED. PHYSICAL DAMAGE TO THE CATHETER MATERIAL CAN RESULT WHEN EXPOSED TO HEAT". A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    AS REPORTED TO ANGIODYNAMICS ON JULY 03, 2018: DURING AN ANGIOGRAPHIC PROCEDURE, AFTER THE ANGIOGRAPHIC CATHETER HAD BEEN PLACED, IT WAS NOTED THE TIP OF THE CATHETER HAD FRACTURED OFF INSIDE OF THE PATIENT. THE TIP REMAINED INSIDE OF THE PATIENT'S PROFUNDA OF HIS LEG. THE TREATING PHYSICIAN WAS UNABLE TO REMOVE THE FRAGMENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577321 SOFT-VU SIZING ANGIOGRAPHIC CATHETER SOFT-VU SIZING ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS, INC 4913592 H787107195035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention