BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT-VU SIZING ANGIOGRAPHIC CATHETER

    MDR report key: 7247641 · Received February 7, 2018

    Report

    Report Number
    1319211-2018-00009
    Event Type
    Injury
    Date Received
    February 7, 2018
    Date of Event
    January 23, 2018
    Report Date
    May 22, 2018
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    DQO
    UDI-DI
    H787107089055
    PMA / PMN Number
    K112452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED WAS A SOFT VU CATHETER. A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THE CATHETER TIP WAS SEPARATED FROM THE CATHETER SHAFT. THE DEVICE MET ALL DIMENSIONAL SPECIFICATIONS FOR THIS PRODUCT. THERE WAS NO EVIDENCE OF OF MATERIAL STRETCHING. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF A TIP FRACTURE CONFIRMED. ALTHOUGH THE COMPLAINT DESCRIPTION IS CONFIRMED, A DEFINITIVE ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED. CAPA (B)(4) 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 DEVICE, STATES; "THE MAXIMUM PRESSURE LIMIT OF CATHETERS INTENDED FOR FLUSH ANGIOGRAPHY IS STATED ON THE CATHETER PACKAGE. WHEN USING A PRESSURE INJECTOR, DO NOT EXCEED THE STATED MAXIMUM PRESSURE." THE IFU ALSO STATES; "DO NOT ATTEMPT TO HAND STRAIGHTEN THE TIP OF ANY CURVED TIPPED CATHETERS WHICH ARE FURNISHED WITH A TIP STRAIGHTENER. THIS MAY RESULT IN DAMAGE TO THE PRODUCT. TIP STRAIGHTENERS ARE FURNISHED ON ALL CATHETERS INTENDED TO BE STRAIGHTENED WITH THE AID OF A TIP STRAIGHTENER. RESHAPING OF THE 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. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED TO ANGIODYNAMICS ON JANUARY 23, 2018: DURING AN ANGIOGRAPHIC PROCEDURE, IT WAS NOTED THE ANGIOGRAPHIC CATHETER HAD FRACTURED INSIDE OF THE PATIENT'S THORACIC AORTA. THE FRACTURED PIECE WAS SUCCESSFULLY REMOVED VIA SNARE. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91888 SOFT-VU SIZING ANGIOGRAPHIC CATHETER SOFT-VU SIZING ANGIOGRAPHIC CATHETER, DQO ANGIODYNAMICS, INC 5024884 H787107089055

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention