BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 1972868 · Received January 28, 2011

    Report

    Report Number
    2939204-2011-00033
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 16, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. DEVICE ANALYSIS REVEALED A PERFORATION ON THE BACK WALL OF THE PROXIMAL INNER SHAFT UNDER THE MANIFOLD, OPPOSITE OF THE INFLATION LUMEN. NO TOOLS ARE INSERTED IN THE MANIFOLD INFLATION PORT DURING CATHETER ASSEMBLY; THEREFORE, IT IS EXTREMELY UNLIKELY THAT AN INNER DAMAGED DURING ASSEMBLY WOULD LINE UP DIRECTLY WITH THE INFLATION PORT ON THE MANIFOLD. ALTHOUGH THE EXACT ROOT CAUSE OF THE REPORTED DAMAGE CANNOT BE DETERMINED; IT IS PROBABLE THAT THE PERFORATION WAS CAUSED BY A NEEDLE/SYRINGE SYSTEM OR GUIDEWIRE USED DURING PREPARATION OF THE DEVICE. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. THEREFORE, A ROOT CAUSE OF HANDLING HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE BALLOON CATHETER, A LEAK WAS OBSERVED. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE BALLOON CATHETER, A LEAK WAS OBSERVED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE M0032072409300 13529037

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR