BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 1854392 · Received October 5, 2010

    Report

    Report Number
    2939204-2010-00973
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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 KINK ADJACENT TO THE EDGE OF THE HUB AND A SECOND KINK 32MM FROM THE EDGE OF THE HUB. MICROSCOPIC INSPECTION REVEALED A PINHOLE IN THE OUTER SHAFT AT THE LOCATION OF THE KINKS. MAGNIFIED INSPECTION OF THE PINHOLE REVEALED NO INDICATION OF ANY CONTRIBUTION FROM MATERIAL OR MANUFACTURING DEFICIENCIES. REVIEW OF THE INFORMATION AVAILABLE FOR THE REPORTED EVENT WAS UNABLE TO DETERMINE AN EXACT ROOT CAUSE. HOWEVER, BASED ON ANALYSIS RESULTS, IT IS POSSIBLE THAT THE DEVICE KINKED DURING HANDLING; WEAKENING THE SHAFT MATERIAL AND RESULTING IN A PINHOLE BURST WHEN PRESSURE WAS APPLIED DURING PROCEDURE. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON CATHETER LEAKED CONTRAST MEDIA AND DEFLATED UPON DILATING. THE PHYSICIAN REMOVED THE BALLOON CATHETER AND REPLACED IT WITH A SIMILAR DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON CATHETER LEAKED CONTRAST MEDIA AND DEFLATED UPON DILATING. THE PHYSICIAN REMOVED THE BALLOON CATHETER AND REPLACED IT WITH A SIMILAR DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE M0032072209150 13511896

    Patients

    Seq Age Sex Outcome Treatment
    1