BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 10701474 · Received October 19, 2020

    Report

    Report Number
    9680794-2020-00444
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    July 27, 2020
    Report Date
    October 8, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE CUSTOMER RETURNED ONE DEFECTIVE PTD CATHETER, ONE PTD ROTATOR, AND TWO LIDSTOCKS (ROTATOR AND PTD CATHETER) FOR ANALYSIS. LARGE AMOUNTS OF DRIED BIOLOGICAL MATERIAL WAS OBSERVED INSIDE THE SHEATH EXTRUSION AND ON THE BODY OF THE ROTATOR. THE LOT NUMBER LISTED ON THE LIDSTOCK FOR THE PTD CATHETER IS 13F20C0595, WHICH DOES NOT GO WITH THE MATERIAL NUMBER PT-65709-C. INSTEAD, THIS LOT NUMBER GOES WITH THE FINISHED KIT PT-65709-W, WHICH CONTAINS PT-65709-C. THEREFORE, IT WAS DETERMINED THAT THE FINISHED KIT INVOLVED WITH THIS COMPLAINT IS PT-65709-W. AS A ROTATOR UNIT IS NOT PACKAGED WITHIN THIS FINISHED KIT, IT IS BEING ASSUMED THAT THE CUSTOMER OPENED A SEPARATE KIT CONTAINING THE ROTATOR. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE PTD TORQUE CABLE HAD SEPARATED DIRECTLY ADJACENT TO THE DISTAL END OF THE METAL TUBING. THE COILS OF THE TORQUE CABLE WERE TWISTED AND DEFORMED AT THE POINT OF SEPARATION INDICATING SIGNIFICANT FORCE BEING APPLIED TO THE DEVICE. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE PTD CABLE SEPARATED APPROXIMATELY 23 5/16" FROM THE PROXIMAL END OF THE BASKET WIRE. THE CUMULATIVE PTD CATHETER LENGTH (ADDED TWO HALVES) MEASURED 30.25", WHICH IS CONSISTENT WITH THE NOMINAL VALUE OF 29 5/8" PER THE CATHETER PTD GRAPHIC. IT IS ASSUMED THAT THE SEPARATION CAUSED THE CABLE TO STRETCH LONGER THAN THE NOMINAL LENGTH. THE OUTER DIAMETER OF THE CABLE ADJACENT TO THE BASKET CONNECTOR MEASURED.0529", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .051"-.054" PER THE CABLE GRAPHIC. FUNCTIONAL INSPECTION COULD NOT BE PERFORMED AS PART OF THIS COMPLAINT INVESTIGATION DUE TO THE DAMAGE TO THE DEVICE. R & D WAS CONSULTED AND IT WAS CONCLUDED THAT THE DAMAGE OBSERVED IS MOST CONSISTENT WITH UNINTENTIONAL USER-ERROR (EXCESSIVE STRESS). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "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 (I.E., RADIUS OF LOOP GRAFT, RADII < 3 CM)". THE REPORT OF A SEPARATED TORQUE CABLE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE PTD TORQUE CABLE HAD SEPARATED DIRECTLY ADJACENT TO THE DISTAL END OF THE METAL TUBING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. IT WAS CONCLUDED THAT THE DAMAGE OBSERVED IS MOST CONSISTENT WITH UNINTENTIONAL USER-ERROR (EXCESSIVE STRESS). BASED ON THE CONDITION OF THE SAMPLE RECEIVED (EVIDENCE OF USE), THE DEFECT OBSERVED AND THE COMMENTS FROM R & D, UNINTENTIONAL USE 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 COMPLAINT IS REPORTED AS: "TURNED LEVER TO LOCK CATHETER INTO ROTATOR AND IT BROKE." NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS STABLE. NO INTERVENTION REQUIRED OTHER THAN TO REMOVE DEVICE AND OPEN A NEW ONE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "TURNED LEVER TO LOCK CATHETER INTO ROTATOR AND IT BROKE." NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS STABLE. NO INTERVENTION REQUIRED OTHER THAN TO REMOVE DEVICE AND OPEN A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165939 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 CATHETER, EMBOLECTOMY DXE ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.