BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F/G GATEWAY OTW OUS 9 X 2.25

    MDR report key: 2884509 · Received December 23, 2012

    Report

    Report Number
    3008853977-2012-00025
    Event Type
    Malfunction
    Date Received
    December 23, 2012
    Date of Event
    September 28, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MINN
    Product Code
    LIT
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTED: DEVICE AVAILABLE FOR EVALUATION - CORRECTED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE CATHETER WAS SEVERELY KINKED ON ITS PROXIMAL SHAFT AT 15.5CM DISTAL TO THE STRAIN RELIEF. THE CATHETER COATING WAS FOUND TO BE CONFORMING TO ITS REQUIRED SPECIFICATIONS. ALL DIMENSIONS WERE WITHIN SPECIFICATION. THE FUNCTIONAL INFLATION TEST USING AN ENCORE INFLATION DEVICE WAS SUCCESSFULLY PERFORMED TO CHECK THE BALLOON FOR LEAKS. THE BALLOON WAS INFLATED FOR 1 HOUR AND 15 MINUTES. THE INFLATION DEVICE PRESSURE WAS MONITORED AND STEADY. THERE WAS NO SIGN OF ANY LEAKS NOTED. MAGNIFIED INSPECTION OF THE INFLATION PORT FOUND A CRACK IN THE HUB OF THE DEVICE BUT NO LEAKS WERE FOUND AT THE CRACK IN THE HUB. NO OTHER ANOMALIES WERE FOUND. THE CAUSE FOR THE OBSERVED KINK AND CRACK IS BELIEVED TO BE RELATED TO THE MANNER THE DEVICE WAS HANDLED. THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. THERE IS NO INDICATION FROM THE INFORMATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATION NONCONFORMANCE. AS PER THE REPORTED INFORMATION, THE BALLOON LEAKED DURING PREPARATION. THE DEVICE LABELING HAS PRECAUTIONS: "DO NOT PREPARE OR PRE-INFLATE THE BALLOON PRIOR TO DEPLOYMENT, OTHER THAN AS DIRECTED. USE BALLOON PURGING TECHNIQUE DESCRIBED IN THE OPERATIONAL INSTRUCTIONS." THERE WERE NO LEAKS FOUND DURING THE INVESTIGATION OF THE DEVICE. THEREFORE, THE REPORTED ISSUE OF THE BALLOON LEAKED WAS NOT CONFIRMED. MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    DURING PREPARATION, IT WAS FOUND THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS FOUND THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F/G GATEWAY OTW OUS 9 X 2.25 CATHETER, BALLOON TYPE LIT BOSTON SCIENTIFIC - MINN 14914149

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR