BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1931956 · Received December 17, 2010

    Report

    Report Number
    2134265-2010-05650
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 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

    (B)(6). (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE FOR ANALYSIS. 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 PROCEDURE A BALLOON RUPTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN A MILDLY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTEBRACHIUM SHUNT AT THE ANASTOMOSIS. A NON BSC GUIDE WIRE AND THE F/G STERLING OTW 5.0 X 20/40 (4F) BALLOON CROSSED THE LESION. ON THE FIRST INFLATION, THE BALLOON WAS INFLATED TO SIX ATMOSPHERES. ON THE SECOND INFLATION THE BALLOON WAS INFLATED TO EIGHT ATMOSPHERES AND A LEAK WAS NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND A PINHOLE RUPTURE WAS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032502040 12038669

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER: STERLING OTW| GUIDE WIRE: TRANSEND 018| INTRODUCER SHEATH: MOSQUITO 5FR| INFLATION DEVICE: ENCORE26