ESOFLIP
Received Dec 8, 2025 · Event occurred Nov 12, 2025
Report 9681384-2025-01319 · MDR key 23742184
Device
Generic name
Esophageal Dilator Balloon With Or Without Ele
Manufacturer
Covidien Ag Juarez (mmj)Model number
ES-330Catalog number
ES-330
Lot number
24K1392JZ
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
- Perforation of Esophagus
- Pain
- Perforation of Esophagus
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, G3, H6 (IME, IMF). 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
IT WAS REPORTED THAT DURING A PROCEDURE, A PATIENT EXPERIENCED AN ESOPHAGEAL PERFORATION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD EXTREME PAIN THAT DID NOT GET BETTER WITH PAIN MEDICINE AND DECREASED OXYGEN DEMAND. THE PERFORATION DIAGNOSED DUE TO BARIUM SWALLOW AND TREATED THROUGH ESOPHAGEAL STENT THEN SURGICAL INTERVENTION. THE CATHETER PASSED PRE-USE CHECK. THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2025.
Additional Manufacturer Narrative
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
IT WAS REPORTED THAT DURING A PROCEDURE, A PATIENT EXPERIENCED AN ESOPHAGEAL PERFORATION AND WAS ADMITTED TO THE HOSPITAL.