BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE FIBER BRAIDED MICROCATHETER

    MDR report key: 2163081 · Received July 15, 2011

    Report

    Report Number
    2134265-2011-03086
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQO
    PMA / PMN Number
    K020012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED THE CATHETER WAS SEVERELY KINKED/STRETCHED FROM 64.5CM TO 79.5CM. DURING FUNCTIONAL TESTING AN APPROPRIATE SIZED MANDREL WAS INSERTED THROUGH THE CATHETER HUB AND RESTRICTION WAS EXPERIENCED 64.5CM FROM THE HUB. PRESSURE WAS APPLIED TO THE MANDREL, ALLOWING IT TO PASS THROUGH THE SECTION AND EXIT THROUGH THE DISTAL TIP. BLOOD ALSO EXITED THE CATHETER AT THIS POINT. ALL DIMENSIONS WHICH WERE MEASURED WERE FOUND TO MEET SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE CONTINUOUS FLUSH DIRECTIONS IN THE DFU WERE NOT FOLLOWED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER BECAME STUCK ON THE GUIDE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). UTILIZING INTERMITTENT FLUSHING, THE RENEGADE FIBER BRAIDED MICROCATHETER WAS ADVANCED OVER A NON BSC GUIDE WIRE AND BECAME STUCK. THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER BECAME STUCK ON THE GUIDE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). UTILIZING INTERMITTENT FLUSHING, THE RENEGADE FIBER BRAIDED MICROCATHETER WAS ADVANCED OVER A NON BSC GUIDE WIRE AND BECAME STUCK. THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE FIBER BRAIDED MICROCATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - CORK M001182480 14152591

    Patients

    Seq Age Sex Outcome Treatment
    1 3FR INTRODUCER SHEATH| SJM TREASURE GUIDE WIRE