MAUDE Adverse Event Report: CROSPON LTD ESOFLIP; ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS

Model Number ES-330

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Esophagus (2399); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a patient with history of achalasia and findings of esophageal spasming and stricturing.First dilation of the patient was up to mid twenties and after this dilation, the diameter was roughly 10 or 12.Eventually, they got to 30 after which the resting diameter was about 16.There had been a relatively little amount of mucosal trauma before the 30 dilation that went more so that would typically have been expected.The patient was sent for a chemical study which did not show perforation and after this, a chest ct scan was eventually performed and showed no obvious esophageal leakage.A repeat chemical study was performed which eventually showed a leak and after the result, the patient went to the operating room for the repair of the tear in the esophagus from the dilation.The patient was hospitalized for approximately 10 days.No repeat procedure was necessary and the patient's last known status was ok and doing well.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ESOFLIP
• Type of Device: ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS
• Manufacturer (Section D): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK
• MDR Report Key: 8452525
• MDR Text Key: 139872685
• Report Number: 3006897778-2019-00004
• Device Sequence Number: 1
• Product Code: PIE
• Combination Product (y/n): N
• PMA/PMN Number: K132337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ES-330
• Device Catalogue Number: ES-330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR