BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1914178 · Received December 3, 2010

    Report

    Report Number
    2134265-2010-05490
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 29, 2010
    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. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN OVER-THE-WIRE STERLING BALLOON CATHETER. VISUAL AND TACTILE INSPECTION OF THE PROXIMAL HUB AND SHAFT PRESENTED NO DAMAGE OR IRREGULARITIES. MICROSCOPIC EXAMINATION OF THE DISTAL END OF THE CATHETER REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL. THE TEAR WAS APPROXIMATELY 30 MM LONG AND APPROXIMATELY CENTERED BETWEEN THE MARKERBANDS. THERE WERE MULTIPLE KINKS IN THE INNER SHAFT OF THE BALLOON. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL AT THE EDGES OF THE TEAR AND THE KINKS IN THE SHAFT PRESENTED NO INDICATION OF AN INITIATION POINT. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, CROSSING DIFFICULTY OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS SHUNT VESSEL. A 5.0X40/40 4F STERLING OVER-THE-WIRE BALLOON WAS ADVANCED BUT WAS UNABLE TO CROSS THE TARGET LESION. IT WAS REMOVED AND A NON-BSC BALLOON WAS ATTEMPTED, BUT IT ALSO WAS UNABLE TO CROSS THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, PRODUCT ANALYSIS REVEALED A BALLOON TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032504040 13591844

    Patients

    Seq Age Sex Outcome Treatment
    1