BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET

    MDR report key: 10493584 · Received September 4, 2020

    Report

    Report Number
    9680794-2020-00356
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 20, 2020
    Report Date
    August 24, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 5FR PTD CATHETER AND LIDSTOCK FOR EVALUATION. VISUAL EXAMINATION REVEALED THE PEBAX TIP WAS FULLY SEPARATED FROM THE PTD BASKET. MICROSCOPIC EXAMINATION CONFIRMED THAT THE BLACK PEBAX TIP BROKE NEAR THE BASE OF THE DISTAL BASKET. THE TIP MATERIAL APPEARED JAGGED AND UNEVEN, INDICATING A STRESS RELATED TEAR. THE SEPARATED PEBAX TIP WAS SEVERELY DISTORTED, TWISTED, AND DEFORMED. ALL THE BASKET WIRES WERE INTACT AND SECURED WITHIN THE BASKET CONNECTORS. THE PTD BASKET WAS ABLE TO ADVANCE AND RETRACT FROM THE SHEATH WITH MINIMAL RESISTANCE. THE PTD CATHETER WAS PLACED INTO A LAB INVENTORY ROTATOR TO FUNCTIONALLY TEST, AND IT WAS ABLE TO ROTATE. NO FUNCTIONAL ISSUES WERE FOUND. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THE KIT WARNS THE USER, "THE PTD DEVICE IS NOT FOR USE IN STENTS." IT ALSO INSTRUCTS THE USER, "IF THE FLEXIBLE TIP "FOLDS OVER" ITSELF WHEN IT ENCOUNTERS THE SHEATH VALVE, INSERT THE FOLDED-OVER TIP THROUGH THE VALVE AND PULL BACK SLIGHTLY TO ALLOW TIP TO UNFOLD IN OPEN CAVITY OF THE HUB. AT THIS POINT, THE DEVICE CAN BE FED THROUGH THE SHEATH INTO THE GRAFT." THE IFU WARNS, "KEEP EXPOSED PORTION OF PTD CATHETER STRAIGHT AT ALL TIMES TO AID IN SUCCESSFUL BASKET DEPLOYMENT. 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. A RAPID WITHDRAWAL RATE OF 1-2 CM/SECOND IS RECOMMENDED WHEN SHARP RADII ARE ENCOUNTERED (I.E. RADIUS OF LOOP GRAFT OR VESSEL, RADII < 3 CM). DO NOT ADVANCE PTD CATHETER FORWARD DURING ACTIVATION." THE CUSTOMER REPORT OF A SEPARATED PTD BASKET TIP WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. A PORTION OF THE BLACK PEBAX TIP WAS SEPARATED AND RETURNED. THE SAMPLE PASSED ALL RELEVANT FUNCTIONAL TESTING AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. A CAPA WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE. THE CAPA ROOT CAUSE DETERMINED TO BE MANUFACTURING - MOLDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE TIP BROKE OFF IN THE PATIENT AND WAS RETRIEVED WITH A BALLOON AND ANOTHER TREROTOLA. THE REPORTED DEFECT WAS DETECTED DURING USE. THERE WAS NO PATIENT INJURY/CONSEQUENCE. PATIENT CONDITION IS REPORTED AS "FINE". THERAPY WAS REPORTED TO BE DELAYED/INTERRUPTED.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    THE TIP BROKE OFF IN THE PATIENT AND WAS RETRIEVED WITH A BALLOON AND ANOTHER TREROTOLA. THE REPORTED DEFECT WAS DETECTED DURING USE. THERE WAS NO PATIENT INJURY/CONSEQUENCE. PATIENT CONDITION IS REPORTED AS "FINE". THERAPY WAS REPORTED TO BE DELAYED/INTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959491 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET CATHETER EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F20E0204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention