BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT:

    MDR report key: 8256627 · Received January 17, 2019

    Report

    Report Number
    9680794-2019-00023
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    January 9, 2019
    Report Date
    January 9, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PROXIMAL CONNECTOR. ALL FOUR OF THE WIRES WERE SECURED TO THE DISTAL CONNECTOR. THE ENDS OF ALL BROKEN BASKET WIRES WERE JAGGED INDICATING A TEAR. MICROSCOPIC EXAMINATION REVEALED THE CONNECTOR WELDS ARE COMPLETE WITHOUT VOIDS. THE ORANGE BASKET LUMEN WAS NOT PRESENT. THE PTD CATHETER BODY WAS INSPECTED AND A SLIGHT KINK WAS OBSERVED ON THE CATHETER BODY NEAR THE JUNCTURE HUB. THE PEBAX BASKET TIP MEASURED 0.59" WHICH IS WITHIN THE SPECIFICATION OF 0.59"-0.61" PER BASKET PRODUCT DRAWING T-65709-008B REV 01. THEREFORE, THE ENTIRE TIP APPEARS TO BE INTACT. THE PTD CATHETER WAS PLACED INTO THE RETURNED ROTATOR TO FUNCTIONALLY TEST THE DEVICE. THE PTD CABLE 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 DISTAL 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 PROXIMAL 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, IT WAS DETERMINED THAT 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 7F PTD CATHETER WIRE SEPARATED DURING USE. THE SEPARATED WIRE WAS RECOVERED WITH OTW SNARE. A DELAY IN TREATMENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE 7F PTD CATHETER WIRE SEPARATED DURING USE. THE SEPARATED WIRE WAS RECOVERED WITH OTW SNARE. A DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51512 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: CATHETER EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F18K0071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention