BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT

    MDR report key: 8818440 · Received July 23, 2019

    Report

    Report Number
    9680794-2019-00265
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 5, 2019
    Report Date
    July 9, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A 7FR PTD CATHETER ATTACHED TO A ROTATOR AND A SEPARATED PTD TIP FOR EVALUATION. THE CATHETER WAS RETURNED WITH THE BASKET FULLY ADVANCED OUT THE SHEATH. DRIED BLOOD WAS OBSERVED ON THE CATHETER, TIP AND ROTATOR. 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 AND THE ENTIRE DISTAL CONNECTOR/TIP HAD SEPARATED. THE BLACK PEBAX TIP REMAINED ATTACHED TO THE DISTAL BASKET CONNECTOR. VISUAL INSPECTION REVEALED THAT THE BASKET WIRES HAD DETACHED FROM THE DISTAL CONNECTOR IN A SIMILAR LOCATION AT THE BASE OF THE CONNECTOR. ALL FOUR OF THE WIRES WERE SECURED TO THE PROXIMAL CONNECTOR AS EXPECTED. MICROSCOPIC EVALUATION OF THE SEPARATION POINTS ON THE BROKEN WIRES REVEALED THEY WERE JAGGED INDICATING A TEAR. INSPECTION OF THE DISTAL CONNECTOR REVEALED PIECES OF THE BASKET REMAINED IN THE WELD HOLES INDICATING THE WIRE ITSELF WAS BROKEN RATHER THAN SEPARATING CLEAN OUT OF THE CONNECTOR WELDS. THE ORANGE INNER LUMEN WAS PRESENT, AND THE DISTAL END WAS CLEAN AND SQUARE, INDICATING IT HAD NOT BEEN DAMAGED WHEN THE CONNECTOR/TIP HAD SEPARATED. THE PTD CATHETER BODY WAS INSPECTED AND A KINK WAS OBSERVED ON THE CATHETER BODY. DESPITE THE DAMAGE, THE BASKET WAS ABLE TO BE FULLY RETRACTED INTO THE SHEATH AS EXPECTED. THE EXPOSED ORANGE INNER LUMEN MEASURED 46 MM IN LENGTH. EACH OF THE BROKEN WIRES MEASURED APPROXIMATELY 34 MM IN LENGTH, INDICATING THEY BROKE IN APPROXIMATELY THE SAME LOCATIONS. THE KINK IN THE SHEATH BODY WAS LOCATED 42 MM FROM THE BOTTOM OF THE PTD JUNCTURE HUB. THE PTD BASKET WAS ABLE TO BE RETRACTED BACK INTO THE SHEATH AS EXPECTED. THE PTD CATHETER WAS ATTACHED TO THE ROTATOR AND THE BASKET ROTATED AS EXPECTED WHEN THE ROTATOR WAS TURNED ON. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE PTD DEVICE 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 REPORT OF A SEPARATED PTD BASKET TIP WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL INSPECTION REVEALED THAT ALL FOUR OF THE PTD WIRES WERE SEPARATED FROM THE DISTAL CONNECTOR/TIP ASSEMBLY. WIRE MATERIAL WAS OBSERVED IN THE CONNECTOR WELD HOLES INDICATING THE WIRE BROKE RATHER THAN SEPARATELY CLEANLY FROM THE WELD HOLES. THE RETURNED SAMPLE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. THIS SUGGESTS THE WELDS WERE SUFFICIENT AND THE CONNECTOR SEPARATED DUE TO A STRESS RELATED WIRE BREAKAGE. 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 THAT THE 7F TREROTOLA CATHETER TIP CAME APART DURING DECLOT PROCEDURE. A SNARE WAS USED TO RETRIEVE THE SEPARATED TIP.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE 7F TREROTOLA CATHETER TIP CAME APART DURING DECLOT PROCEDURE. A SNARE WAS USED TO RETRIEVE THE SEPARATED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609628 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT CATHETER, EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F19C0277

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN.| UNKNOWN.