BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 11995432 · Received June 14, 2021

    Report

    Report Number
    9680794-2021-00292
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 25, 2021
    Report Date
    May 31, 2021
    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 ONE DEFECTIVE PTD CATHETER, ONE PTD ROTATOR FOR ANALYSIS. LARGE AMOUNTS OF DRIED BIOLOGICAL MATERIAL WERE OBSERVED INSIDE THE SHEATH EXTRUSION AND ON THE BODY OF 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 1132 MM FROM THE PROXIMAL END OF THE BASKET WIRE. THE TWO SECTIONS OF THE PTD CATHETER MEASURED 1187 MM AND 124 MM , TOTALING 1311 MM, OR 51.6", WHICH IS NOT CONSISTENT WITH THE NOMINAL VALUE OF 29.625" PER THE CATHETER PTD GRAPHIC. IT IS HYPOTHESIZED THAT EITHER THE CUSTOMER RETURNED THE INCORRECT CATHETER OR REPORTED THE WRONG MATERIAL/LOT NUMBERS. THE OUTER DIAMETER OF THE CABLE ADJACENT TO THE BASKET CONNECTOR MEASURED 0.05335", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.051"-0.054" PER THE CABLE GRAPHIC. 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. BASED ON THE SAMPLE RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE CORRECT CATHETER WAS NOT RETURNED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DOCTOR FOUND THE BASKET WIRE WAS BROKEN AND SEPARATED BY THE MACHINE'S ROTATION. NO PATIENT HARM REPORTED. THE D EVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DOCTOR FOUND THE BASKET WIRE WAS BROKEN AND SEPARATED BY THE MACHINE'S ROTATION. NO PATIENT HARM REPORTED. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888644 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 CATHETER, EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F19G0634

    Patients

    Seq Age Sex Outcome Treatment
    1