BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI STICK MAX

    MDR report key: 9740567 · Received February 21, 2020

    Report

    Report Number
    1317056-2020-00022
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    January 13, 2020
    Report Date
    April 13, 2020
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DRE
    UDI-DI
    H965457591
    PMA / PMN Number
    K132713
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 5F INTRODUCER FOR EVALUATION. VISUAL/MICROSCOPIC EXAM: AS RECEIVED, THE DILATOR HUB WAS DETACHED FROM THE DILATOR TUBING AS REPORTED BY THE CUSTOMER. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION IS CONFIRMED. THE 5F INTRODUCER IS A PURCHASED ACCESSORY FROM SUPPLIER (B)(4). SCAR004061 AND THE RETURNED COMPLAINT SAMPLE WERE SENT TO (B)(4) FOR EVALUATION, DHR REVIEW OF SUPPLIER LOT, ROOT CAUSE DETERMINATION AND CORRECTIVE ACTION. AS PER (B)(4), LLC'S EVALUATION REPORT: THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. HOWEVER, IT WAS MISSING THE INNER CANNULA. THUS, A FULL EVALUATION WAS NOT POSSIBLE. CUTTING OPEN THE HUB SHOWED THERE WAS A FULL CAPTURE ON BOTH THE EXTRUSION AND THE CANNULA. NO FURTHER EVALUATION IS POSSIBLE WITHOUT THE CANNULA. THE REST OF THE EVALUATION SHOWED THE LOT TO BE ACCEPTABLE. ROOT CAUSE IS UNKNOWN. 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. LABELING REVIEW: DIRECTION FOR USE {DFU}: WARNING: CONTENTS SUPPLIED STERILE USING AN ETHYLENE OXIDE (EO) PROCESS. DO NOT USE IF STERILE BARRIER IS DAMAGED. IF DAMAGE IS FOUND, CALL YOUR NAVILYST MEDICAL REPRESENTATIVE. INSPECT PRIOR TO USE TO VERIFY THAT NO DAMAGE HAS OCCURRED IN SHIPPING. FOR SINGLE PATIENT USE ONLY. DO NOT REUSE, REPROCESS OR RESTERILIZE. REUSE, REPROCESSING OR RESTERILIZATION MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE AND/OR LEAD TO DEVICE FAILURE WHICH, IN TURN, MAY RESULT IN PATIENT INJURY, ILLNESS OR DEATH. 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 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 YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM 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 BY THE END USER: I USED A DEFECTIVE MICROPUNCTURE SHEATH YESTERDAY. THE LUER LOCK PART OF THE INNER DILATOR SNAPPED OF AFTER WE INTRODUCED TO THE BODY. ITEM NUMBER IS 45-759 L: 5544060. THE INTRODUCER SHAFT REMAINED IN THE PATIENT. THE PIECE WAS RETRIEVED, THE METAL PART OF THE INNER DILATOR IS STILL ON THE MICRO WIRE. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT WAS NOT HARMED. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204732 MINI STICK MAX VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE ANGIODYNAMICS 5544060 H965457591

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention