BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 18255296 · Received December 4, 2023

    Report

    Report Number
    1317056-2023-00169
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 6, 2023
    Report Date
    July 17, 2024
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DRE
    UDI-DI
    H965457540
    PMA / PMN Number
    K132713
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** THE INFORMATION IN THIS REPORT HAS BEEN CORRECTED TO MATCH THE DATA SUBMITTED IN GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID). REFERENCE (B)(4). CORRECTIONS: D4: MODEL #, UDI.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF GUIDEWIRE TIP DETACHED WAS NOT CONFIRMED SINCE NO COMPLAINT SAMPLE WAS RETURNED. WITHOUT RECEIVING THE COMPLAINT SAMPLE FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. THE GUIDEWIRE DEVICE IS SUPPLIED TO ANGIODYNAMICS BY THE SUPPLIER/MANUFACTURER HERAEUS MEDICAL. (B)(4) WAS SENT TO HERAEUS FOR DHR REVIEW OF THE REPORTED LOT NUMBER. (B)(4)RESPONSE STATED THAT NO DEVIATIONS OR NONCONFORMANCES RELATED TO THE [TIP DETACHED] EVENT DESCRIPTION WERE IDENTIFIED IN THE RECORD REVIEW. THERE IS NO EVIDENCE TO CONFIRM THE ISSUE IS DUE TO THE MANUFACTURING PROCESS. THIS EVENT IS CONSIDERED A NON-MANUFACTURING-RELATED ISSUE. A POTENTIAL ROOT CAUSE FOR THIS TYPE OF GUIDEWIRE TIP DETACHED WITHIN THE VASCULATURE FAILURE MODE IS END USER TECHNIQUE IN PULLING GUIDEWIRE BACK AGAINST THE NEEDLE TIP BEVEL. THIS IS CAUTIONED AGAINST IN DEVICE DIRECTIONS FOR USE. 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: DIRECTION FOR USE (16600601-01) IS PROVIDED WITH THIS MINI-STICK DEVICE. THE FAILURE MODE OF DEVICE FRACTURE AND EMBOLIZATION IS CAUTIONED AS POTENTIAL ADVERSE EVENT. NO SAMPLE WAS RETURNED FOR EVALUATION SO IT CANNOT BE DETERMINED IF DEVICE WAS USED IN A MANNER INCONSISTENT WITH LABELING. ADVERSE EVENTS GUIDEWIRE SHEARING, FRACTURE OR EMBOLIZATION. OPERATIONAL INSTRUCTIONS 1. PRIOR TO INSERTION, FLUSH ALL COMPONENTS WITH SALINE OR HEPARINIZED/SALINE. 2. GAIN PERCUTANEOUS ACCESS WITH THE 21 G (0.9 MM) VASCULAR INTRODUCER NEEDLE. 3. ADVANCE THE 0.018 INCH (0.46 MM) GUIDEWIRE THROUGH THE NEEDLE. CAUTION: THE GUIDEWIRE SHOULD NOT BE WITHDRAWN THROUGH THE INTRODUCER NEEDLE. IF THE GUIDEWIRE MUST BE WITHDRAWN WHILE STILL INSIDE THE NEEDLE, SIMULTANEOUSLY REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT TO PREVENT THE NEEDLE FROM DAMAGING THE GUIDEWIRE. 4. WITHDRAW THE INTRODUCER NEEDLE, LEAVING THE 0.018 INCH (0.46 MM) GUIDEWIRE IN PLACE. 5. ADVANCE THE COAXIAL ASSEMBLY OVER THE 0.018 INCH (0.46 MM) GUIDEWIRE. 6. SIMULTANEOUSLY REMOVE THE DILATOR AND 0.018 INCH (0.46 MM) GUIDEWIRE, WHILE HOLDING THE SHEATH PORTION OF THE ASSEMBLY IN PLACE. 7. ADVANCE A 0.035 INCH (0.89 MM) OR 0.038 INCH (0.97 MM) GUIDEWIRE INTO THE SHEATH. 8. REMOVE THE SHEATH, LEAVING THE 0.035 INCH (0.89 MM) OR 0.038 INCH (0.97 MM) WIRE. 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

    AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A MINI STICK MAX 5F X 10CM STD .018 SS/SS ECHO 2.75" PG. DURING A PROCEDURE, PART OF THE MICROPUNCTURE SEARED OFF, INSIDE OF THE PATIENT, DURING WITHDRAWAL. THE FRAGMENT DID NOT REQUIRE THE USE OF A SNARE TO REMOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WAS NO REPORT OF PATIENT HARM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER DETAILS; HOWEVER, THIS HAS BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604616 ANGIODYNAMICS DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE ANGIODYNAMICS 45754 5787808 H965457540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown