BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT

    MDR report key: 7283359 · Received February 20, 2018

    Report

    Report Number
    9680794-2018-00039
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    February 2, 2018
    Report Date
    February 6, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A 7FR PTD CATHETER AND A PTD ROTATOR FOR EVALUATION. THE RETURNED CATHETER HAD EVIDENCE OF USE IN THE FORM OF DRIED BLOOD. THE CUSTOMER REPORTED THAT THE "MIDDLE OF THE CATHETER WAS CUT OFF"; HOWEVER, THE PTD CATHETER BODY OF THE RETURNED DEVICE APPEARED TO BE INTACT AND NO DAMAGE TO THE CATHETER BODY OR PTD CABLE WAS OBSERVED. HOWEVER, THE BLACK PEBAX TIP WAS SEPARATED ON THE RETURNED SAMPLE. VISUAL EXAMINATION OF THE PTD TIP REVEALED THAT THE BLACK TIP BROKE AT THE BASE OF THE DISTAL CONNECTOR EXPOSING THE END CAP AND THE INNER ORANGE LUMEN. THE PROTRUDING ORANGE LUMEN WAS OBSERVED TO BE TWISTED/DEFORMED ADJACENT TO THE CONNECTOR, ALTHOUGH THERE IS NO INDICATION IT WAS TORN. THE PEBAX MATERIAL AT THE EDGE OF THE TIP APPEARED UNEVEN AND ROUGH INDICATING A TEAR. THE SEPARATED TIP PIECE WAS ALSO CONSISTENT WITH A TEAR. THE INNER ORANGE LUMEN WAS SECURE IN THE PROXIMAL CONNECTOR. THE BASKET APPEARED TYPICAL AND NO OTHER DEFECTS OR DAMAGE WAS OBSERVED WITH THE BASKET ASSEMBLY. THE PTD CATHETER BODY WAS INSPECTED AND NO KINKS/DAMAGE/ANOMALIES WERE OBSERVED ON THE CATHETER BODY OR THE PTD CABLE. THE PTD CATHETER WAS INSPECTED WITH THE BASKET RETRACTED AND WITH THE BASKET ADVANCED AND NO DEFECTS WERE OBSERVED. THE REMAINING PORTION OF THE BLACK PEBAX TIP ATTACHED TO THE BASKET MEASURED APPROXIMATELY 1.5 MM IN LENGTH AND THE SEPARATED TIP MEASURED 14 MM. THE COMBINED TIP LENGTH 0.610" IS WITHIN THE SPECIFICATION. THE ORANGE LUMEN PROTRUDING FROM THE BASKET MEASURED 8 MM IN LENGTH. 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 BODY WAS INTACT AND FUNCTIONING PROPERLY. THE BASKET WAS ABLE TO BE RETRACTED AND ADVANCED WITHIN THE SHEATH WITH MINIMAL RESISTANCE. THE ORANGE LUMEN REMAINED SECURELY ATTACHED TO THE PROXIMAL CONNECTOR ASSEMBLY WHEN TUGGED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE PTD CATHETER AND NO RELEVANT MANUFACTURING ISSUES 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, STAT ES 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 THAT THE PTD CATHETER BODY WAS DAMAGED; HOWEVER, THE BLACK PEBAX TIP OF THE PTD BASKET WAS SEPARATED FROM THE BASKET CONNECTOR ON THE RETURNED SAMPLE (THE CATHETER BODY WAS UNDAMAGED). THE REMAINING PORTION OF THE BASKET TIP WAS ATTACHED TO THE DISTAL END OF THE BASKET ASSEMBLY AND THE BROKEN EDGE WAS FRAYED INDICATING A TEAR. 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. A CONCLUSION CODE COULD NOT BE CHOSEN AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS: THE MD WAS PERFORMING THE PROCEDURE ACCORDING TO THE IFU. THEN THE MIDDLE OF THE CATHETER WAS CUT OFF. THEREFORE, MD COULD NOT PROCEED WITH THE PRODUCT, AND THE SAME PRODUCT WAS USED WITHOUT ANY ABNORMALITY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: THE MD WAS PERFORMING THE PROCEDURE ACCORDING TO THE IFU. THEN THE MIDDLE OF THE CATHETER WAS CUT OFF. THEREFORE, MD COULD NOT PROCEED WITH THE PRODUCT, AND THE SAME PRODUCT WAS USED WITHOUT ANY ABNORMALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126385 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT CATHETER, EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F16J0207

    Patients

    Seq Age Sex Outcome Treatment
    1