BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2083545 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01827
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH BLOOD AND CONTRAST IN THE GUIDE WIRE LUMEN AND ON THE BALLOON. NO DAMAGE WAS FOUND TO THE DEVICE. THE MARKERBAND SPACING AND DISTANCE FROM THE BALLOON CONE TRANSITIONS WERE MEASURED WHILE THE BALLOON WAS INFLATED TO NOMINAL PRESSURE AND FOUND TO BE WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER PREFERENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-01837 IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, INCORRECT POSITIONING OF RO MARKERBANDS WERE NOTED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL. THE DIFFUSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, 6MM IN DIAMETER, SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 100/135 STERLING BALLOON CATHETER WAS SELECTED TO POST-DILATE ANOTHER MANUFACTURERS' STENT IN THE SFA. THE BALLOON WAS INFLATED ONCE TO 8ATMS WHEN IT WAS NOTED THE PROXIMAL RO MARKERBAND WAS 3-5MM DISTAL TO THE SHOULDER OF THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED. ANOTHER 6.0 X 100/135 STERLING BALLOON CATHETER WAS THEN USED FOR STENT POST-DILATION. THE BALLOON WAS INFLATED ONCE TO 8ATMS WHEN IT WAS NOTED THE PROXIMAL RO MARKERBAND WAS NOT IN THE CORRECT LOCATION. THE PROCEDURE WAS COMPLETED WITH THIS BALLOON CATHETER. THE INFLATED BALLOONS WERE BOTH UNIFORM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-01837. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, INCORRECT POSITIONING OF RO MARKERBANDS WERE NOTED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT COMMON FEMORAL. THE DIFFUSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, 6MM IN DIAMETER, SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 100/135 STERLING BALLOON CATHETER WAS SELECTED TO POST-DILATE ANOTHER MANUFACTURERS' STENT IN THE SFA. THE BALLOON WAS INFLATED ONCE TO 8ATMS WHEN IT WAS NOTED THE PROXIMAL RO MARKERBAND WAS 3-5MM DISTAL TO THE SHOULDER OF THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED. ANOTHER 6.0 X 100/135 STERLING BALLOON CATHETER WAS THEN USED FOR STENT POST-DILATION. THE BALLOON WAS INFLATED ONCE TO 8ATMS WHEN IT WAS NOTED THE PROXIMAL RO MARKERBAND WAS NOT IN THE CORRECT LOCATION. THE PROCEDURE WAS COMPLETED WITH THIS BALLOON CATHETER. THE INFLATED BALLOONS WERE BOTH UNIFORM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032601010 13593778

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR ABBOTT MIRACLE BROTHER GUIDE WIRE