BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI STICK MAX

    MDR report key: 9530388 · Received December 30, 2019

    Report

    Report Number
    1317056-2019-00158
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    December 8, 2019
    Report Date
    March 5, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS WAS UNABLE TO PERFORM A DEVICE EVALUATION. THE SUPPLIER OF THIS DEVICE WAS NOTIFIED OF THE EVENT VIA (B)(4) AND REQUESTED TO PERFORM A DEVICE HISTORY RECORD REVIEW. AS PER THE (B)(4) REPORT, MEDRON, LLC, THE LOT FILE FOR 703447 AND 76302 WAS REVIEWED FOR ANY POSSIBLE CAUSES THAT COULD HAVE RESULTED IN THE SCAR. THE SUPPLIER IDENTIFIED A MANUFACTURING ISSUE AS THE ROOT CAUSE. SUPPLIER CORRECTION/CORRECTIVE ACTIONS: INSTRUCTION/TRAINING. THE MANUFACTURING PROCEDURE THAT DEMONSTRATES THE PROPER PROCEDURE FOR MINI STICK SHEATH MOLDING IS BEING UPDATED WITH CLARIFYING PICTURES AND INSTRUCTIONS THAT WILL FURTHER DEMONSTRATE ACCEPTABLE AND IMPROPERLY LOADED EXTRUSIONS ON CORE PINS. AS WELL AS CLARIFYING THAT THIS STEP TO VERIFY THE EXTRUSION HAVE BEEN LOADED PROPERLY MUST BE PERFORMED WHEN THE CASSETTE HAS BEEN LOADED INTO THE MOLD. ALL MOLD OPERATORS WILL BE TRAINED TO THESE UPDATES. 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: DIRECTIONS 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. REUSE, REPROCESSING OR RESTERILIZATION MAY ALSO CREATE A RISK OF CONTAMINATION OF THE DEVICE AND/OR CAUSE PATIENT INFECTION OR CROSS-INFECTION, INCLUDING, BUT NOT LIMITED TO, THE TRANSMISSION OF INFECTIOUS DISEASE(S) FROM ONE PATIENT TO ANOTHER. CONTAMINATION OF THE DEVICE MAY LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. AFTER USE, DISPOSE OF PRODUCT AND PACKAGING IN ACCORDANCE WITH HOSPITAL, ADMINISTRATIVE AND OR LOCAL GOVERNMENT POLICY. DEVICE DESCRIPTION. THE MINI STICK* MAX COAXIAL MICROINTRODUCER KIT CONTAINS: (1) COAXIAL SHEATH/DILATOR ASSEMBLY; (1) 21 G (0.9 MM) VASCULAR INTRODUCER NEEDLE; AND (1) 0.018 INCH (0.46 MM) FLOPPY TIP GUIDEWIRE. INTENDED USE/ INDICATIONS FOR USE. THE COAXIAL MICROINTRODUCER KIT IS USED FOR THE PERCUTANEOUS INTRODUCTION OF A GUIDEWIRE INTO THE VASCULAR SYSTEM. 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

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    AS REPORTED: PROCEDURE: LEFT HEART CATH, GAINING MICROPUNCTURE ACCESS. HUB DETACHED FROM SHEATH LEAVING SHEATH INSIDE PATIENTS RIGHT FEMORAL ARTERY. THEY HAD TO DO A CUT-DOWN IN ORDER TO REMOVE SHEATH FROM PATIENTS BODY. IT WAS REPORTED THE PATIENT DID NOT SUFFER ANY PERMANENT HARM OR INJURY DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326412 MINI STICK MAX VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE ANGIODYNAMICS 5534700 H965457591

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention