BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT

    MDR report key: 4202693 · Received July 17, 2014

    Report

    Report Number
    2247686-2014-00003
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA, RISK ANALYSIS, AND FMEA DOCUMENTATION HAS BEEN INITIATED TO IDENTIFY AND ADDRESS POSSIBLE ROOT CAUSES. THIS INFO WILL BE INCLUDED IN THE COMPLAINT FILE LOCATED AT THE ARTEGRAFT FACILITY. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    AN ARTEGRAFT DISTRIBUTER CALLED ARTEGRAFT TO REQUEST A RETURN FOR ARTEGRAFT AG630, #(B)(4). AN END-USER HOSPITAL REPORTED THAT THE GRAFT HAD UNREPAIRABLE LEAKAGE AT A BRANCH SITE. ARTEGRAFT CONTACTED THE HOSPITAL WHERE THE EVENT OCCURRED TO OBTAIN ADDITIONAL INFO. THE LEAKAGE WAS OBSERVED DURING THE SALINE FLUSHING PRE-SURGICAL PREPARATION, AS RECOMMENDED IN THE ARTEGRAFT IFU. THERE WAS NO PT INVOLVEMENT. THE SURGERY CONTINUED USING AN ALTERNATE GRAFT. ARTEGRAFT RECEIVED THE RETURNED ARTEGRAFT AG630, # (B)(4), ON (B)(4)2014. INITIAL INSPECTION OCCURRED ON (B)(4) 2014. FUNCTIONAL TESTING AND ADDITIONAL VISUAL INSPECTION OCCURRED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420624 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC. AG630 13K237-003

    Patients

    Seq Age Sex Outcome Treatment
    1