BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2121007 · Received June 13, 2011

    Report

    Report Number
    2134265-2011-02238
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE. THERE WAS A PINHOLE 3 MM FROM THE PROXIMAL SIDE OF THE DISTAL MARKERBAND. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS IILIAC. A STERLING MONORAIL 5.0 X 40/135 (4F) PERCUTANEOUS BALLOON DILATION CATHETER WAS INFLATED TO 15ATMS WHEN A BALLOON RUPTURE OCCURRED ON THE INITIAL INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT CONDITION IS REPORTED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS IIILAC. A STERLING MONORAIL 5.0 X 40/135 (4F) PERCUTANEOUS BALLOON DILATION CATHETER WAS INFLATED TO 15ATMS WHEN A BALLOON RUPTURE OCCURRED ON THE INITIAL INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT CONDITION IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031504010 14194980

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: CRUISE| INTRODUCER SHEATH: GOOD MAN6F 11CM