BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW-TREROTOLA PTD KIT

    MDR report key: 3896611 · Received June 17, 2014

    Report

    Report Number
    3896611
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ELDERLY MAN HAD A DE-CLOTTING PROCEDURE AND ANGIOPLASTY OF HIS ARTERIO-VENOUS HEMODIALYSIS FISTULA. IN ADDITION TO END STAGE RENAL DISEASE, THE PATIENT HAS A HISTORY OF MULTIPLE ABDOMINAL SURGERIES AND GASTROINTESTINAL BLEEDING, TWO HIP REPLACEMENTS, CORONARY ARTERY DISEASE, HYPERPARATHYROIDISM, BLINDNESS IN HIS RIGHT EYE AND ALSO HEARING IMPAIRMENT. A 5-FR. ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE WAS USED TO PERFORM THE PROCEDURE, WHICH INCLUDED MECHANICAL THROMBECTOMY AND ANGIOPLASTY AS WELL AS PHARMACOLOGIC THROMBOLYSIS. DURING THE THROMBECTOMY, THE DEVICE ADHERED TO THE VEIN ITSELF, AND AN ESTIMATED 6-7 MM OF THE RUBBER TIP OF THE CATHETER FRACTURED, BECOMING EMBEDDED IN THE VEIN. IT WAS NOT POSSIBLE TO RETRIEVE THE FRAGMENT OF THE CATHETER TIP. THE PATIENT WAS OBSERVED POST PROCEDURE WITH NO APPARENT ADVERSE EFFECTS. HIS CONDITION WILL BE FREQUENTLY MONITORED DURING HIS DIALYSIS VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355924 ARROW-TREROTOLA PTD KIT CATHETER, PERIPHERAL, ATHERECTOMY, PTD MCW ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) 5 FR X 65 CM 13F14D0004

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR DIALYSIS| CARDIAC DRUGS| OTHER