BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR GUIDEWIRE

    MDR report key: 16273415 · Received January 31, 2023

    Report

    Report Number
    1317056-2023-00012
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 20, 2023
    Report Date
    May 10, 2023
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQX
    UDI-DI
    H965457471
    PMA / PMN Number
    K070150
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF GUIDEWIRE TIP DETACHED INSIDE THE PATIENT WAS NOT CONFIRMED; THE GUIDEWIRE SAMPLE WAS NOT RETURNED. WITHOUT RECEIVING THE COMPLAINT SAMPLE FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. POTENTIAL ROOT CAUSE FOR THIS TYPE OF GUIDEWIRE FAILURE MODE IS THE END USER PULLING THE GUIDEWIRE BACK AGAINST THE NEEDLE IF RESISTANCE TO ADVANCEMENT IS OBSERVED. DHR REVIEW OF THE INDICATED PACKAGING LOT SHOWED NO DEVICE NON-CONFORMANCE AT THE TIME OF DEVICE DISTRIBUTION. THE GUIDEWIRE IN QUESTION IS A FINISHED PACKAGED GOOD THAT IS PURCHASED FROM HERAEUS MEDICAL. HERAEUS MEDICAL WAS MADE AWARE OF THIS REPORTED EVENT VIA FYI SCAR00004741 . 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: DFU PROVIDED WITH THIS GUIDEWIRE DEVICE CONTAINS THE FOLLOWING STATEMENTS: DIRECTIONS: INSERT THE GUIDEWIRE INTO THE NEEDLE AND ADVANCE THE GUIDEWIRE TO THE TARGETED LOCATION. THE GUIDEWIRE TIP CAN BE VISUALIZED UNDER FLUOROSCOPY DURING INSERTION. ONCE THE GUIDEWIRE IS INSERTED, REMOVE THE NEEDLE. DO NOT ADVANCE THE GUIDEWIRE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE HAS BEEN DETERMINED. CAUTIONS: DO NOT ADVANCE THE VASCULAR GUIDEWIRE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE GUIDEWIRE AND CATHETER OR VESSEL PERFORATION. NAVILYST MEDICAL, INC. DOES NOT RECOMMEND A PARTICULAR TECHNIQUE FOR THE USE OF THIS DEVICE. THE STEPS CONTAINED IN THE PRECEDING DIRECTIONS DISCUSS THE SELDINGER TECHNIQUE FOR PERCUTANEOUS ENTRY AND ARE OF INFORMATION PURPOSES ONLY. EACH PHYSICIAN SHOULD EVALUATE THEIR APPROPRIATENESS ACCORDING TO INDIVIDUAL PATIENT CONDITIONS AND HIS OR HER MEDICAL TRAINING AND EXPERIENCE. 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 TERRITORY MANAGER REPORTED AN END USER EXPERIENCED A PROCEDURE IN WHICH THEY HAD AN ISSUE USING A GUIDEWIRES, NITINOL .018X145CM, TUNGSTEN COIL, HYDROPHILIC KIT. DURING THE PROCEDURE, IT WAS REPORTED THE TIP OF THE GUIDEWIRE DETACHED INSIDE THE PATIENT. THE TIP WAS SUCCESSFULLY RETRIEVED; HOWEVER, THE PROCEDURE WAS NOT CONTINUED. 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
    789534 VASCULAR GUIDEWIRE VASCULAR GUIDEWIRE, NITINOL W/ HYDROPHILIC COATING, STRAIGHT, RADIOPAQUE TIP DQX ANGIODYNAMICS UNKNOWN H965457471

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown