BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOSCAN

    MDR report key: 20305248 · Received September 25, 2024

    Report

    Report Number
    3007662958-2024-00009
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    September 5, 2024
    Report Date
    December 6, 2024
    Manufacturer
    GIVEN IMAGING VIETNAM CO LTD
    Product Code
    FFX
    UDI-DI
    04260167482446
    PMA / PMN Number
    K091070
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE OUTER LAYER OF TPE WAS DAMAGED AND BEGAN ROLLING UP ON ITSELF. THE CATHETER HAD BEEN CUT IN MULTIPLE PLACES. IT WAS REPORTED THAT THE MANOMETRY CATHETER WAS DIFFICULT TO REMOVE FROM PATIENT AND THE MANOMETRY CATHETER WAS DAMAGED. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN PATIENT'S NOSE. ENT (EAR, NOSE, THROAT) TEAM TOOK ONE OF ENT (EAR, NOSE, THROAT) SCOPES AND CUT THE DEVICE TO GET IT OUT OF PATIENT'S NOSE. FORCEPS WAS ALSO USED TO REMOVE THE CATHETER FROM THE PATIENT. THE CATHETER WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291805 MANOSCAN SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX GIVEN IMAGING VIETNAM CO LTD 3890 04260167482446

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R