BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R-PORT PREMIER

    MDR report key: 468522 · Received June 25, 2003

    Report

    Report Number
    6000126-2003-00053
    Event Type
    Injury
    Date Received
    June 25, 2003
    Date of Event
    March 21, 2002
    Report Date
    April 18, 2002
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PLACEMENT OF THIS R-PORT IN 2002, THE GUIDE BROKE AND A PORTION REMAINED IN THE PT. THE DETACHED PORTION WAS RETRIEVED SURGICALLY. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT ARE AVAILABLE AT THIS TIME. SHOULD ADD'L DETAILS BECOME AVAILABLE, A SUPPLEMENT WILL BE FORWARDED AT THIS TIME. THIS DEVICE HAS NOT BEEN RECEIVED FOR EVAL. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. A LOT SEARCH WAS PERFORMED AND REVEALED NO OTHER COMPLAINTS TO DATE ON THIS LOT NUMBER. WITHOUT EVALUATING THE DEVICE CO IS UNABLE TO DETERMINE IF THE DEVICE MET IS SPECIFICATIONS. CO BELIEVES USER TECHNIQUE, AND/OR PT ANATOMY MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, CO IS UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R-PORT PREMIER VASCULAR ACCESS SYSTEM LJT BOSTON SCIENTIFIC NA 4107681

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention