MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) ESOFLIP; ESOPHAGEAL DILATOR BALLOON WITH OR WITHOUT ELE

Model Number	ES-330
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: es-330, catheter es-330 30mm eso dilation (lot#24f0465jz); es-330, catheter es-330 30mm eso dilation (lot#24f0465jz); es-330, catheter es-330 30mm eso dilation (lot#24f0465jz) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the transportation sheath was attached to the balloon.The electrostatic discharge (esd) cover was attached to the printed circuit board (pcb).The balloon was not wet.The balloon electrodes were not corroded.There was no observed corrosion on the pcb pads.The syringe was not attached to the catheter.There were no kinks on the catheter line.Saline was tested and the saline was out of specification.This will cause the d-est to values to be out of specification.The catheter passed functional testing with lab saline.It was reported that the catheters failed pre-use check.The most likely cause was determined to be manufacturing related.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.
Event or Problem Description
It was reported that, both catheters failed pre-use check.The customer tried the pre-use check twice on each catheter.Another catheter from another lot was used to resolve the issue.There was no patient harm.Medtronic's initial evaluation of the incident device found that the saline was out of specification.

• Brand Name: ESOFLIP
• Common Device Name: ESOPHAGEAL DILATOR BALLOON WITH OR WITHOUT ELE
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23835939
• Report Number: 9681384-2025-01371
• Device Sequence Number: 14719547
• Product Code: PID
• UDI-Device Identifier: 10884521809451
• UDI-Public: (01)10884521809451(17)260215(10)24F0465JZ(20)03
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2026
• Device Model Number: ES-330
• Device Catalogue Number: ES-330
• Device Lot Number: 24F0465JZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2038-2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown