BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBAL LUMEN SUPPORT

    MDR report key: 5441092 · Received February 17, 2016

    Report

    Report Number
    1820334-2016-00129
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Report Date
    January 28, 2016
    Manufacturer
    COOK INC
    Product Code
    HFJ
    PMA / PMN Number
    K932114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL WAS FILED WITHIN THE 30 DAY TIME FRAME REGARDLESS OF CORRECTED DATE (ADDITIONAL INFORMATION PROVIDED/UPDATED): INVESTIGATION/EVALUATION: THE COMPLAINT PRODUCT WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION; HOWEVER, DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, AND INSTRUCTIONS FOR USE (IFU) OF THE PRODUCT WAS CONDUCTED. THE CUSTOMER REPORTED THAT "PART OF THE DEVICE MIGRATED OUTSIDE OF THE FALLOPIAN TUBE." ADDITIONAL INFORMATION PROVIDED (B)(6) 2016 STATED "IT WAS DETERMINED THAT THE TUBE WAS COMPLETELY INTACT SO NO FURTHER ACTION IS NEEDED." THE TUBAL LUMEN SUPPORT IS INTENDED TO PROVIDE "SUPPORT TO THE FALLOPIAN TUBE DURING AN ANASTOMOSIS PROCEDURE." AN IFU IS PROVIDED WITH THIS DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED (B)(6) 2016 AS TO WHETHER TO "INTACT TUBE" WAS REFERRING TO THE FALLOPIAN TUBE OR THE MEDICAL DEVICE. AS OF (B)(6) 2016, THIS INFORMATION HAS NOT BEEN PROVIDED. IT IS REASONABLE TO ASSUME BASED ON THE CUSTOMER'S PROVIDED STATEMENT ON (B)(6) 2016 THAT THE TUBE HAD NOT SEPARATED INTO TWO SECTIONS. BASED ON THE LIMITED INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT, NO FURTHER RISK REDUCTION ACTIVITIES ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, PART OF THE TUBAL LUMEN SUPPORT CATHETER MIGRATED OUTSIDE OF THE FALLOPIAN TUBE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE TUBE WAS COMPLETELY INTACT. NO INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, PART OF THE TUBAL LUMEN SUPPORT CATHETER MIGRATED OUTSIDE OF THE FALLOPIAN TUBE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99267 TUBAL LUMEN SUPPORT HFJ PROSTHESIS, FALLOPIAN TUBE HFJ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other