BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2863104 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07263
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WAS CONTRAST IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE. POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER AND A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL 6 MM FROM THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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 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 PROCEDURE (PTCA), BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS LEFT CEPHALIC VEIN. A 6.0 X 40/80 STERLING BALLOON CATHETER WAS USED TO DILATE THE LESION BUT RUPTURED AT 13ATMS ON THE 1ST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE (PTCA), BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS LEFT CEPHALIC VEIN. A 6.0 X 40/80 STERLING BALLOON CATHETER WAS USED TO DILATE THE LESION BUT RUPTURED AT 13ATMS ON THE 1ST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032604080 15408053

    Patients

    Seq Age Sex Outcome Treatment
    1 4FR TERUMO 5CM GUDING INTRODUCER| MASTER GUIDE WIRE