BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 8169471 · Received December 17, 2018

    Report

    Report Number
    1317056-2018-00230
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    November 27, 2018
    Report Date
    March 11, 2019
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    UDI-DI
    H965458810
    PMA / PMN Number
    K121089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED FOR THE INDICATED 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. AS RECEIVED, THE GUIDEWIRE WAS RETURNED IN TWO PIECES. REFERENCE ATTACHED PICTURE. THE GUIDEWIRE FROM THE REPORTED EVENT WAS RETURNED TO ANGIODYNAMICS IN TWO PIECES. AS THIS IS A PURCHASED DEVICE, THE SAMPLE WAS FORWARDED TO THE SUPPLIER, HERAEUS MEDICAL COMPONENTS FOR EVALUATION, ROOT CAUSE DETERMINATION, CORRECTIVE ACTION AND DHR OF THE SUPPLIER LOT. AS PER HERAEUS MEDICAL'S REPORT, THE RETURNED SAMPLE WAS REVIEWED BY QUALITY AND DEVELOPMENT ENGINEERS. THE CORE HAD BROKEN BROKE FROM THE ASSEMBLY AT APPROXIMATELY 1.1CM FROM THE DISTAL END OF THE GUIDEWIRE. THIS PIECE DID NOT SEPARATE FROM THE DISTAL BOND. IT WAS BENT AND APPEARED TO HAVE BEEN BROKEN AS A RESULT OF BEING PULLED AGAINST RESISTANCE. THE COIL WAS KINKED BUT DID NOT SEPARATE FROM THE ASSEMBLY. ALSO, SOME SECTION OF THE COIL WAS STRETCHED WHICH SUGGEST THAT THE COIL WAS PULLED. NECK OUTER DIAMETER FOR CORES ARE CONTROLLED DURING THE GRINDING PROCESS AND CHECKED EVERY 150 MINUTES USING A LASER PROFILER. 100% INSPECTION FOR DISTAL BOND OUTER DIAMETER IS PERFORMED DURING THE ASSEMBLY OF THE GUIDEWIRE AND VERIFIED AT FINAL INSPECTION. ALTHOUGH THE ROOT CAUSE OF THE EVENT CANNOT BE DEFINITIVELY DETERMINED, IT IS LIKELY THE RESULT OF USER ERROR, IN PULLING THE WIRE AGAINST RESISTANCE UNTIL IT FAILED. HERAEUS MEDICAL HAS NO CORRECTIVE NO CORRECTIVE ACTION SPECIFIC TO THE PRODUCT MENTIONED ABOVE. HERAEUS MEDICAL PERFORMED A DHR REVIEW OF THE REPORTED LOT AND FOUND NO INDICATION OF A MANUFACTURING DEFECT THAT COULD HAVE IMPACTED THE REPORTED EVENT. THE DIRECTIONS FOR USE PACKAGED WITH THE PICC DEVICE INCLUDE PRECAUTIONS REGARDING GUIDEWIRE USE INCLUDING, " IF GUIDEWIRE MUST BE WITHDRAWN, REMOVE THE NEEDLE AND GUIDEWIRE AS A SINGLE UNIT. " (B)(4).

    Additional Manufacturer Narrative · 1

    WHILE IT HAS BEEN INDICATED THAT THE GUIDEWIRE FROM THE REPORTED EVENT WILL BE RETURNED, IT HAS NOT YET ARRIVED. WHEN IT IS AVAILABLE, IT WILL BE SENT FOR EVALUATION TO (B)(4), ANGIODYNAMICS' SUPPLIER, ALONG WITH A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), DURING A PICC PLACEMENT PROCEDURE, "DOCTOR TRIED TO MANIPULATE THE GUIDEWIRE BUT NOTICE BUCKLING OF DISTAL GUIDEWIRE, ABOUT 1CM FROM THE DISTAL TIP. DOCTOR 'WITHDRAWN' THE GUIDEWIRE BUT GUIDEWIRE WAS BROKEN AND SHORT SEGMENT OF GUIDEWIRE WAS RETAINED INSIDE UPPER BRACHIAL VEIN. 'DOCTOR 'ATTEMPT' TO PERFORM ANOTHER PUNCTURE AT BRACHIAL VEIN AT CUBITAL FOSSA ARTERY WAS DONE WITH MIESO-PUNCTURE SET AND 5FR SHEATH WAS INSERTED'. THE RETAINED GUIDEWIRE WAS FINALLY RETRIEVED WITH FORCEPS ENDOVASCULARLY VIA THE 5FR SHEATH. NO RETAINED GW WAS NOTED AT RIGHT ARM AND CHEST AFTER RETRIEVAL CHECKED BY XRAY. PATIENT CONDITION WAS SAFE." IT HAS BEEN INDICATED THAT THE USED GUIDEWIRE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008992 ANGIODYNAMICS PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS 5373696 H965458810

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention