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

Model Number	ES-330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Uf/importer rpt num: (b)(4).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
According to the reporter, a 63-year old has had dysphagia.She had previous esophagogastroduodenoscopy (egd) with dilation.The patient was informed of the higher risk, including perforation for this procedure.The procedure was performed with 30mm dilating balloon under endoscopic guidance.The maximum dilation diameter of the fundoplication reached 27mm.Upon deflating the balloon, there was a large mucosal tear of the mucosa in the distal esophagus.The patient required admission for 12 days and an esophageal stent replacement.
Additional Manufacturer Narrative
Corrected (h11): please note that the h11 narrative submitted previously contained an invalid user facility reference # ((b)(4)).It was determined that this reference was improperly constructed by the user facility and used erroneously on a voluntary 3500 form sent to the manufacturer.Please disregard this number as a valid cross-reference.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
According to the reporter, a 63-year-old has had dysphagia.She had previous esophagogastroduodenoscopy (egd) with dilation.The patient was informed of the higher risk, including perforation for this procedure.The procedure was performed with 30mm dilating balloon under endoscopic guidance.The maximum dilation diameter of the fundoplication reached 27mm.Upon deflating the balloon, when balloon was removed there was a large mucosal tear of the mucosa in the distal esophagus.The patient required admission for 12 days and an esophageal stent replacement.On (b)(6) 2024, an esophagogastroduodenoscopy with fluoroscopy with stent placement was performed.The stent placed was a wallflex stent 18 mm x103.On (b)(6) 2024, esophagogastroduodenoscopy was performed due to the stent had migrated about 2 cm.Stent was pulled back.And on (b)(6) 2024 esophagogastroduodenoscopy was performed to remove stent.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19510556
• Report Number: 9681384-2024-00086
• Device Sequence Number: 17008357
• Product Code: PID
• UDI-Device Identifier: 10884521809451
• UDI-Public: 10884521809451
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2025
• Device Model Number: ES-330
• Device Catalogue Number: ES-330
• Device Lot Number: 23L0338JZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/21/2024
• Date Device Manufactured: 12/07/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White