BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 10806337 · Received November 8, 2020

    Report

    Report Number
    9680794-2020-00441
    Event Type
    Malfunction
    Date Received
    November 8, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 15, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A ROTATOR AND PTD CATHETER PRODUCT LIDSTOCK, 7 FR PTD CATHETER, ROTATOR, AND SHEATH FOR EVALUATION. THE RETURNED COMPONENTS CONTAINED OBVIOUS SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL. VISUAL EXAMINATION REVEALED THE PTD BASKET WAS SEPARATED FROM THE CATHETER ASSEMBLY. THE BASKET WELDS APPEARED TO BE BROKEN AND PULLED FROM THE CATHETER. MICROSCOPIC EXAMINATION CONFIRMED THE BROKEN WELDS WERE STILL WITHIN THE CATHETER. THE ORANGE INNER LUMEN APPEARED TO BE COMPLETELY SEPARATED FROM THE CATHETER. THE PEBAX TIP APPEARED FULL WITH NO MISSING PIECES. THE PTD CATHETER WAS ABLE TO ADVANCE AND RETRACT WITHIN THE SHEATH. THE ROTATOR WAS ACTIVATED AND THE CATHETER ROTATED AS EXPECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOT NUMBER RECEIVED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THIS KIT WARNS 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 CUSTOMER REPORT OF PTD BASKET SEPARATION WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE PTD BASKET, ORANGE INNER LUMEN, AND PEBAX TIP WERE SEPARATED FROM THE PTD CATHETER. THE BASKET WIRES APPEARED TO BE BROKEN ADJACENT TO THE WELDS WITHIN THE CONNECTOR OF THE PTD CATHETER, INDICATING UNDUE FORCE LIKELY CAUSED THIS DAMAGE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON THE LIDSTOCK PROVIDED WITH NO RELEVANT FINDINGS. BASED ON THE CONDITION OF THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: DURING PROCEDURE WHILE USING TREROTOLA. TREROTOLA BROKE OFF IN VENOUS OUTFLOW OF FISTULA. DR. (B)(6) AWARE AND USED SNARE TO RETRIEVE BROKEN PIECE. POST RETRIEVAL OF BROKEN PIECE ANGIOGRAPHY WAS DONE AND SHOWED NO LEFTOVER PIECES. NO PATIENT INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING PROCEDURE WHILE USING TREROTOLA. TREROTOLA BROKE OFF IN VENOUS OUTFLOW OF FISTULA. DOCTOR AWARE AND USED SNARE TO RETRIEVE BROKEN PIECE. POST RETRIEVAL OF BROKEN PIECE ANGIOGRAPHY WAS DONE AND SHOWED NO LEFTOVER PIECES. NO PATIENT INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271358 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 CATHETER, EMBOLECTOMY DXE ARROW INTERNATIONAL INC. UNKNOWN

    Patients

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