BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALECOT

    MDR report key: 3191465 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04337
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GBW
    PMA / PMN Number
    K811378
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UNSPECIFIED PROCEDURE DEVICE BREAKAGE OCCURRED. A MALECOT CATHETER HAD BEEN ADVANCED AND AT AN UNSPECIFIED TIME, THE DISTAL PORTION OF THE CATHETER BROKE OFF IN THE PATIENT'S STOMACH. A GASTROSTOMY WAS PERFORMED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290001 MALECOT CATHETER, PERITONEAL GBW BOSTON SCIENTIFIC - SPENCER M001224110 0015714630

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention