BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5

    MDR report key: 11214424 · Received January 22, 2021

    Report

    Report Number
    9680794-2021-00011
    Event Type
    Injury
    Date Received
    January 22, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 5, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE 5FR PTD CATHETER, ROTATOR, AND LIDSTOCK FOR EVALUATION. VISUAL EXAMINATION REVEALED THE PEBAX TIP WAS FULLY SEPARATED FROM THE PTD BASKET AND NOT RETURNED FOR EVALUATION. MICROSCOPIC EXAMINATION CONFIRMED THE BASKET WIRES WERE FULLY WELDED. THE RETURNED PTD BASKET WAS ABLE TO BE RETRACTED AND ADVANCED FROM THE PTD CATHETER. THE RETURNED PTD CATHETER WAS ASSEMBLED WITH THE RETURNED ROTATOR. WHEN THE ROTATOR BUTTON WAS DEPRESSED, THE PTD CATHETER PERFORMED AS EXPECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE INSTRUCTIONS-FOR-USE 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 A SEPARATED PTD TIP WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE PTD PEBAX TIP WAS COMPLETELY SEPARATED FROM THE BASKET AND WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. A CAPA HAS PREVIOUSLY BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. THE ROOT CAUSE HAS BEEN DETERMINED TO BE A MANUFACTURING (MOLDING) ISSUE. CORRECTIVE ACTIONS HAVE NOT YET BEEN IMPLEMENTED.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "WHILE USING THE DEVICE IN THE PATIENT'S VEIN, THE DEVICE BECAME EMBEDDED IN THE WALL OF THE VESSEL AND THE MOTOR SOUNDED LIKE IT WAS SUDDENLY BOGGED DOWN. THE PHYSICIAN IMMEDIATELY STOPPED PRESSING THE ROTATIONAL TRIGGER AND THE PATIENT ALERTED US THAT SHE WAS IN EXTREME PAIN. THE PHYSICIAN THEN TRIED TO REMOVE THE DEVICE AND IT WAS "STUCK". THE PHYSICIAN THEN HAD TO APPLY PRESSURE TO THE VESSEL AND REMOVE THE DEVICE WITH MODERATE FORCE. THIS WAS DONE UNDER FLUOROSCOPIC GUIDANCE. THE DEVICE CAME OUT OF THE SHEATH EASILY BUT IT WAS THEN OBSERVED THAT THE ATRAUMATIC NOSE CONE TIP WAS MISSING. UNDER FLUORO IT WAS OBSERVED TO BE SITTING AT THE SPOT WHERE THE CATHETER FIRST HAD TROUBLE. THE PHYSICIAN THEN PLACED A STENT TO JAIL THE TIP FROM MIGRATING INTO THE CENTRAL VEINS." THE PATIENT'S CONDITION IS REPORTED AS FINE. THE PATIENT WAS SCHEDULED TO HAVE A FOLLOW-UP FISTULAGRAM AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "WHILE USING THE DEVICE IN THE PATIENT'S VEIN, THE DEVICE BECAME EMBEDDED IN THE WALL OF THE VESSEL AND THE MOTOR SOUNDED LIKE IT WAS SUDDENLY BOGGED DOWN. THE PHYSICIAN IMMEDIATELY STOPPED PRESSING THE ROTATIONAL TRIGGER AND THE PATIENT ALERTED US THAT SHE WAS IN EXTREME PAIN. THE PHYSICIAN THEN TRIED TO REMOVE THE DEVICE AND IT WAS "STUCK". THE PHYSICIAN THEN HAD TO APPLY PRESSURE TO THE VESSEL AND REMOVE THE DEVICE WITH MODERATE FORCE. THIS WAS DONE UNDER FLUOROSCOPIC GUIDANCE. THE DEVICE CAME OUT OF THE SHEATH EASILY BUT IT WAS THEN OBSERVED THAT THE ATRAUMATIC NOSE CONE TIP WAS MISSING. UNDER FLUORO IT WAS OBSERVED TO BE SITTING AT THE SPOT WHERE THE CATHETER FIRST HAD TROUBLE. THE PHYSICIAN THEN PLACED A STENT TO JAIL THE TIP FROM MIGRATING INTO THE CENTRAL VEINS." THE PATIENT'S CONDITION IS REPORTED AS FINE. THE PATIENT WAS SCHEDULED TO HAVE A FOLLOW-UP FISTULAGRAM AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109967 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5 CATHETER EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F19C0218

    Patients

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