BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDOFLIP CATHETER

    MDR report key: 18986670 · Received March 27, 2024

    Report

    Report Number
    3006897778-2024-00001
    Event Type
    Injury
    Date Received
    March 27, 2024
    Report Date
    March 27, 2024
    Manufacturer
    CROSPON LTD
    Product Code
    FFX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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, DURING EQUIPMENT SET UP, THE SYRINGE HAD BECOME LOOSE/DETACHED AND WAS RE-SECURED USING A TAPE. DURING THE USE OF THE CATHETER, THERE WAS REPORTEDLY ¿A TEAR THAT NEARLY RESULTED IN A PERFORATION¿ BECAUSE THE CATHETER MEASUREMENTS BEING DISPLAYED WERE INCORRECT. THE CUSTOMER USED THE SYSTEM AGAIN, AND RECEIVED AN ERROR CODE DURING PRECHECK, AND SO THE EQUIPMENT WAS NOT UTILIZED. THE SALES REPRESENTATIVE AND CUSTOMER ATTEMPTED TO TEST ONE OF THE CATHETERS, WHICH WAS GIVING NOTABLY ERRONEOUS READINGS. THE CATHETER'S CORRECT PLACEMENT WAS ENDOSCOPICALLY CONFIRMED AND IT INFLATED CORRECTLY WITH THE FLUID GOING IN. THE FLUID WAS GOING IN AND COULD SEE THE WAIST. THE WAIST WENT AWAY BUT NOT IN A DILATING WAY BUT IT WAS NOT READING OVER 12 MILLIMETER EVEN THOUGH FLUID WAS INSERTING. THE PHYSICIAN THOUGHT THE BALLOON HAD POPPED AND CONTINUED PUTTING IN FLUID. THE DOCTOR ENDOSCOPICALLY LOOKED AND THEY COULD SEE THE BALLOON WAS ALMOST ENTIRELY INFLATED, AND STILL THE READING 12 MILLIMETER INFLATED. WHEN DEFLATED, THERE WAS A VERY DRAMATIC DILATION, THE FLUOROSCOPY HAD NO PERFUSION, WITH LARGE LACERATION. THE SYSTEM WAS NOT RELAYING ACCURATE INFORMATION AND THE CATHETER DID NOT FAIL PRE-CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467957 UNKNOWN ENDOFLIP CATHETER SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LTD UNKNOWN ENDOFLIP CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R