BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT

    MDR report key: 8232554 · Received January 9, 2019

    Report

    Report Number
    9680794-2019-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 26, 2018
    Report Date
    December 26, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A 7FR PTD CATHETER AND A PTD ROTATOR FOR EVALUATION. THE PTD CATHETER AND ROTATOR WAS VISUALLY INSPECTED. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE PTD ROTATOR AND THE PTD CABLE. ALL FOUR OF THE PTD BASKET WIRES WERE BROKEN ON THE RETURNED SAMPLE. VISUAL INSPECTION REVEALED THAT THE BASKET WIRES WERE DETACHED FROM THE DISTAL CONNECTOR. ALL FOUR OF THE WIRES WERE SECURED TO THE PROXIMAL CONNECTOR. MICROSCOPIC EXAMINATION REVEALED THE CONNECTOR WELDS ARE COMPLETE WITHOUT VOIDS. THE ORANGE LUMEN WAS PRESENT, BUT IT WAS DEFORMED ADJACENT TO THE CONNECTION POINT WHERE THE WIRES WOULD HAVE CONNECTED TO THE WELDS OF THE PTD TIP. THE PTD CATHETER BODY WAS INSPECTED AND A KINK WAS OBSERVED ON THE CATHETER BODY. THE ENDS OF ALL BROKEN BASKET WIRES WERE JAGGED INDICATING A TEAR. THE PEBAX BASKET TIP MEASURED 0.59" WHICH IS WITHIN THE SPECIFICATION OF 0.59"-0.61" PER BASKET PRODUCT DRAWING. THEREFORE, THE ENTIRE TIP APPEARS TO BE INTACT. THE KINK IN THE CATHETER BODY WAS LOCATED NEAR THE PROXIMAL END AT 40MM FROM THE ORANGE CONNECTOR. THE PTD CATHETER WAS PLACED INTO THE RETURNED ROTATOR TO FUNCTIONALLY TEST THE DEVICE. THE PTD BASKET ROTATED AS EXPECTED WHEN THE ACTIVATION BUTTON WAS PRESSED, INDICATING THE PTD CATHETER WAS INTACT AND FUNCTIONING PROPERLY. A MANUAL TUG ON ALL FOUR WIRES REVEALED THAT THEY WERE SECURED TO THE PROXIMAL CONNECTOR ASSEMBLY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING ISSUE. THE IFU PROVIDED WITH THE KIT WARNS THE USER, "DO NOT ADVANCE PTD CATHETER FORWARD DURING ACTIVATION." THE IFU ALSO CAUTIONS, POTENTIAL FATIGUE FAILURE OF PTD TORQUE CABLE AND FRAGMENTATION BASKET MAY OCCUR WITH PROLONGED ACTIVATION OF PTD DEVICE. WHEN USING THE PTD WITHIN THE APEX OF A FOREARM LOOP GRAFT, LIMIT OPERATION TO 3 MINUTES OR LESS TO REDUCE THE POTENTIAL FOR BASKET FAILURE. A RAPID WITHDRAWAL RATE OF 1-2 CM/SECOND IS RECOMMENDED WHEN SHARP RADII ARE ENCOUNTERED". THE CUSTOMER REPORT OF A DAMAGED PTD BASKET WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL INSPECTION REVEALED THAT THE PTD WIRES WERE SEPARATED FROM THE DISTAL CONNECTION POINT. THE RETURNED SAMPLE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS ALSO PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED CAUSE. BASED ON THE OBSERVED DAMAGE AND THE CUSTOMER DESCRIPTION, UNINTENTIONAL USER ERROR LIKELY 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: THE TIP OF 7F TREROTOLA PT-65509-WC DEVICE DETACHED IN A PATIENT DURING STANDARD FISTULA DECLOT PROCEDURE. INTERVENTION - THE PHYSICIAN HAD TO SNARE THE TIP TO REMOVE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: THE TIP OF 7F TREROTOLA PT-65509-WC DEVICE DETACHED IN A PATIENT DURING STANDARD FISTULA DECLOT PROCEDURE. INTERVENTION - THE PHYSICIAN HAD TO SNARE THE TIP TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24863 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT CATHETER EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F18J0371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention