BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT

    MDR report key: 7984459 · Received October 19, 2018

    Report

    Report Number
    9680794-2018-00230
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 CATHETER WAS RETURNED FULLY ATTACHED TO THE ROTATOR AND THE DISTAL PORTION OF THE PEBAX TIP WAS SEPARATED. VISUAL EXAMINATION IDENTIFIED THAT THE PEBAX TIP SEPARATED NEAR ITS MIDDLE, EXPOSING THE INNER ORANGE LUMEN. THE SEPARATION POINT WAS SLIGHTLY JAGGED, BUT UNIFORM. THE EXPOSED LUMEN WAS SLIGHT BEND/KINKED. THE PTD CATHETER BODY WAS INSPECTED AND ONE MAJOR KINK WAS OBSERVED NEAR THE PROXIMAL END OF THE CATHETER. NO DEFECTS OR ANOMALIES WERE FOUND ON THE PTD CABLE OR ROTATOR. THE PTD CATHETER WAS INSPECTED WITH THE BASKET RETRACTED AND WITH THE BASKET ADVANCED AND NO DEFECTS WERE OBSERVED. THE PTD CATHETER CONTAINED ONE KINK 565 MM FROM THE DISTAL END OF THE CATHETER. THE ORANGE INNER LUMEN PROTRUDED 11 MM PAST THE BASKET TIP. THE SEPARATED PORTION OF THE PEBAX TIP MEASURED TO BE 0.118" AND THE PORTION ATTACHED TO THE CATHETER MEASURED TO BE 0.472". THIS MEANS THAT 0.59" OF PEBAX WAS RETURNED , WHICH IS WITHIN THE NOMINAL SPECIFICATION OF 0.060" PER PRODUCT DRAWING. THE RETURNED PTD CABLE WAS ABLE TO RETRACT AND ADVANCE FROM THE PTD CATHETER WITH SIGNIFICANT RESISTANCE. THE RETURNED PTD CATHETER WAS CONNECTED TO THE RETURNED ROTATOR TO FUNCTIONALLY TEST THE COMPONENTS. WHEN THE BUTTON WAS DEPRESSED, THE CATHETER ROTATED AS EXPECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS PRODUCT STATES UNDER GENERAL WARNINGS THAT THE PTD DEVICE IS NOT FOR USE IN STENTS. IT PROVIDES INSTRUCTIONS IN THE EVENT THE BLACK FLEXIBLE BASKET TIP "FOLDS OVER" ITSELF AND WHILE IN USE, STATES THAT THE EXPOSED PORTION OF THE CATHETER IS TO BE KEPT STRAIGHT AT ALL TIMES TO AID IN SUCCESSFUL BASKET DEPLOYMENT. IT WARNS THAT THE ROTATING BASKET IS TO BE WITHDRAWN IN THE DEPLOYED POSITION PRIOR TO REACHING THE SHEATH AT A RECOMMENDED RATE OF 1-2CM/SECOND WHEN SHARP RADII IS ENCOUNTERED AND THAT THE CATHETER IS NOT TO BE ADVANCED FORWARD DURING ACTIVATION. IT ALSO WARNS THAT POTENTIAL FATIGUE FAILURE OF THE PTD CABLE AND FRAGMENTATION BASKET MAY OCCUR WITH PROLONGED ACTIVATION OF THE PTD DEVICE. THE IFU ALSO PROVIDES VARIOUS WARNINGS AND PRECAUTIONS FOR THE USER TO REEVALUATE TREATMENT OR TO CONSIDER ALTERNATIVE TREATMENTS IF THERE IS A PRESENCE OF VENOUS OUTFLOW STENOSIS GREATER THAN 10CM LONG , UNTREATABLE CONDITIONS OR LARGE PSEUDO ANEURYSM. THE CUSTOMER REPORTED ISSUE THAT THE PTD CATHETER TIP WAS SEPARATED WAS CONFIRMED DURING THE COMPLAINT INVESTIGATION. THE REMAINING PORTION OF THE BASKET TIP WAS ATTACHED TO THE DISTAL END OF THE BASKET ASSEMBLY AND THE BROKEN EDGE WAS SMOOTH AND UNIFORM. AN INCREASE IN THE OCCURRENCE RATE FOR PTD TIP SEPARATION COMPLAINTS HAS RESULTED IN A CAPA INVESTIGATION. THE MANUFACTURING PROCESS HAS NOT BEEN SHOWN AS A CAUSE AND THE SAMPLES HAVE MET THE TENSILE SPECIFICATION. THEREFORE, THE CAUSE OF THIS COMPLAINT IS UNDETERMINED AND FURTHER INVESTIGATION OF THIS ISSUE WILL BE DOCUMENTED UNDER THE CAPA.

    Description of Event or Problem · 0

    THE DISTAL RUBBER TIP BROKE OFF DURING DECLOT PROCEDURE AND WAS SNARED OUT BY DR. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: THE DISTAL RUBBER TIP BROKE OFF DURING DECLOT PROCEDURE AND WAS SNARED OUT BY DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823716 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT CATHETER, EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F17H0064

    Patients

    Seq Age Sex Outcome Treatment
    1