BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET

    MDR report key: 10372752 · Received August 6, 2020

    Report

    Report Number
    9680794-2020-00323
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 22, 2020
    Report Date
    July 23, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 5FR PTD CATHETER AND LIDSTOCK FOR EVALUATION. THE PTD BASKET AND TIP CONTAINED OBVIOUS SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL. 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 A LAB INVENTORY 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 AS A MANUFACTURING (MOLDING) ISSUE. CORRECTIVE ACTIONS HAVE NOT YET BEEN IMPLEMENTED.

    Description of Event or Problem · 0

    THE SOFT 'CONE' FROM A PTD ENDED UP BREAKING OFF IN A PATIENT. THIS WAS NOT OVER THE WIRE, SO DIDN'T HAVE EASY ACCESS TO IT. PROBABLY COULD HAVE TRIED TO SNARE IT OUT, BUT NEEDED TO STENT GRAFT ACROSS THE ANASTOMOSIS FOR AN ELASTIC STENOSIS ANYWAY. THE USER INDICATES EVERYTHING WORKED OUT FINE, IT WAS A DYING GRAFT ANYWAY (4 SURGICAL REVISIONS IN THE LAST 6 MONTHS) AND THE USER WAS ALREADY PLANNING NEW ACCESS ON THE RIGHT.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    THE SOFT 'CONE' FROM A PTD ENDED UP BREAKING OFF IN A PATIENT. THIS WAS NOT OVER THE WIRE, SO DIDN'T HAVE EASY ACCESS TO IT. PROBABLY COULD HAVE TRIED TO SNARE IT OUT, BUT NEEDED TO STENT GRAFT ACROSS THE ANASTOMOSIS FOR AN ELASTIC STENOSIS ANYWAY. THE USER INDICATES EVERYTHING WORKED OUT FINE, IT WAS A DYING GRAFT ANYWAY (4 SURGICAL REVISIONS IN THE LAST 6 MONTHS) AND THE USER WAS ALREADY PLANNING NEW ACCESS ON THE RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837756 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET CATHETER EMBOLECTOMY DXE ARROW INTERNATIONAL INC. 13F19F0445

    Patients

    Seq Age Sex Outcome Treatment
    1