BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT

    MDR report key: 7938257 · Received October 5, 2018

    Report

    Report Number
    9680794-2018-00200
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 5, 2018
    Report Date
    September 17, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A 5FR PTD CATHETER ASSEMBLY, A PERCUTANEOUS SHEATH INTRODUCER (PSI) AND A PTD ROTATOR FOR EVALUATION. THE PTD CATHETER WAS ADVANCED THROUGH THE PSI AND THE PTD BASKET WAS FULLY ADVANCED. DRIED BLOOD WAS OBSERVED ON EACH OF THE RETURNED COMPONENTS. VISUAL EXAMINATION OF THE PTD CATHETER REVEALED THAT THE SHEATH WAS DAMAGED AT THE DISTAL TIP WHERE THE BASKET EXITS. THE SHEATH BODY WAS ALSO TWISTED/DEFORMED IN SEVERAL LOCATIONS ALONG THE BODY INDICATING THE PTD CATHETER INSIDE WAS STUCK. AFTER FUNCTIONAL TESTING CONFIRMED THE BASKET COULD NOT BE RETRACTED WITHIN THE SHEATH, THE SHEATH BODY WAS CUT OPEN USING A SCALPEL. SIGNIFICANT DRIED BLOOD WAS OBSERVED WITHIN THE SHEATH BODY (INCLUDING AT THE DISTAL TIP) WHICH COULD HAVE CAUSED THE FUNCTIONAL FAILURE. VISUAL EXAMINATION OF THE PTD BASKET, PSI AND ROTATOR DID NOT REVEAL ANY DEFECTS OR ANOMALIES. THE BASKET PROXIMAL CONNECTOR CAP OUTER DIAMETER MEASURED 0.0519" WHICH IS WITHIN THE SPECIFICATION OF 0.050-0.052" PER PTD CATHETER PRODUCT DRAWING. A SECTION OF THE SHEATH BODY WAS REMOVED AND THE INNER DIAMETER MEASURED 0.056" WHICH IS WITHIN THE SPECIFICATION OF 0.055"-0.059" PER SHEATH ASSEMBLY PRODUCT DRAWING. THE PSI SHEATH TIP INNER DIAMETER MEASURED 0.083" WHICH IS WITHIN THE SPECIFICATION OF 0.083"-0.085" PER PSI PRODUCT DRAWING. THE PTD CATHETER WAS ABLE TO BE REMOVED FROM THE PSI WITH MINIMAL RESISTANCE. THE PTD CATHETER WAS RETURNED WITH THE BASKET FULLY ADVANCED OUT OF THE SHEATH ASSEMBLY. SIGNIFICANT RESISTANCE WAS MET WHILE ATTEMPTING TO RETRACT THE BASKET BACK WITHIN THE SHEATH BY PULLING ON THE TORQUE CABLE. THE RETURNED ROTATOR FUNCTIONED AS EXPECTED WHEN THE ON/OFF BUTTON WAS PUSHED. THE RETURNED PTD CATHETER WAS INSERTED INTO THE ROTATOR, AND WHEN THE ON BUTTON WAS PUSHED, THE CATHETER DID NOT ROTATE. THE PTD CATHETER APPEARED TO BE STUCK WITHIN THE SHEATH WHICH WAS EXPECTED BASED ON THE FUNCTIONAL TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE PTD CATHETER ASSEMBLY AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THIS PRODUCT DESCRIBES SUGGESTED TECHNIQUES FOR OPERATION OF THE PTD CATHETER. IT CONTAINS THE WARNING "POTENTIAL FATIGUE FAILURE OF THE PTD TORQUE CABLE AND FRAGMENTATION BASKET MAY OCCUR WITH PROLONGED ACTIVATION OF PTD DEVICE. THE CUMULATIVE ACTIVATION TIME OF THE PTD DEVICE IN ALL RADII SHOULD BE LIMITED TO 30-60 SECONDS" FOR OPERATION. THE IFU INSTRUCTS THE USER "WITH TWO PASSES COMPLETED, REMOVE GUIDEWIRE (IF APPLICABLE) AND DEVICE IN COMPRESSED POSITION FROM GRAFT OR FISTULA. ASPIRATE APPROXIMATELY 5 ML OF HOMOGENIZED CLOT VIA TH E VENOUS SHEATH, IF POSSIBLE, AND DISCARD ASPIRATE. CLOSED SYSTEM MAY PREVENT ASPIRATION" BUT ALSO WARNS "CONTINUED UNSUCCESSFUL ASPIRATION MAY COLLAPSE SHEATH AND GRAFT/ FISTULA. TWO PASSES ARE RECOMMENDED BUT ADDITIONAL PASSES MAY BE REQUIRED TO COMPLETELY MACERATE THROMBUS." THE IFU ALSO INSTRUCTS THE USER TO "FLUSH CATHETER LUMEN WITH HEPARINIZED SALINE AND MANUALLY REMOVE ANY ACCUMULATED FIBRIN FROM FRAGMENTATION BASKET" AFTER INITIAL USE. THE CUSTOMER REPORT THAT THE PTD BASKET COULD NOT BE RETRACTED BACK INTO THE SHEATH WAS CONFIRMED THROUGH FUNCTIONAL EVALUATION OF THE RETURNED SAMPLE. THE PTD CATHETER WAS RETURNED WITH THE BASKET FULLY ADVANCED AND COULD NOT BE RETRACTED WITHIN THE SHEATH. THE SHEATH BODY WAS CUT OPEN AND SIGNIFICANT DRIED BLOOD WAS OBSERVED WITHIN THE BODY. THE PTD BASKET OD AND THE SHEATH BODY ID BOTH MET DIMENSIONAL REQUIREMENTS AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE RETURNED SAMPLE AND THE TIME OF DISCOVERY, IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS: WE DEPLOYED THE DEVICE AND USED IT TO BUST UP SOME CLOT. WE THEN TRIED TO REMOVE SO WE COULD CLEAN OUT THE CLOT AND USE IT AGAIN. THE DEVICE WOULD NOT CLOSE. WE TRIED EVERYTHING WE COULD THINK OF TO GET IT TO CLOSE.

    Additional Manufacturer Narrative · 1

    (B)(4). POTENTIAL LOT# 13F18F0781.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: WE DEPLOYED THE DEVICE AND USED IT TO BUST UP SOME CLOT. WE THEN TRIED TO REMOVE SO WE COULD CLEAN OUT THE CLOT AND USE IT AGAIN. THE DEVICE WOULD NOT CLOSE. WE TRIED EVERYTHING WE COULD THINK OF TO GET IT TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781322 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT CATHETER, EMBOLECTOMY DXE ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1