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

Model Number ES-330

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Vomiting (2144); Stenosis (2263); Perforation of Esophagus (2399); Blood Loss (2597); Radiation Exposure, Unintended (3164)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient's esophagus was perforated during the procedure for diagnostic/dilation.It was noted that egd (esophagogastroduodenoscopy) did not show very tight les (lower esophageal sphincter).The catheter was inserted and showed di 0.3-0.5.The physician was confused, as the numbers did not match what was seen on egd or barium swallow.The physician wanted to do empiric dilation because the patient was symptomatic, a typical chest pain after eating.Dilation went okay with the dilation catheter ¿ 60cc, 24.4cm.There was no scope during dilation and after, the scope was inserted and did not see obvious perforation, but it saw a good amount of bleeding that was more than usual.The patient did well after, had a mild chest discomfort and went home.The next day, the patient experienced more chest pain, left chest, got barium swallow, not definitive for perforation.A ct scan on the next day showed extravasation of contrast (leak).The patient was admitted to the hospital for 2 weeks on antibiotics and npo (nothing by mouth) for few days.A repeat ct scan still showed leak, so patient was put in esophageal stent.The endoscopist at that time stated that the tear looked to be 7cm, but the physician did not believe it was that big or else the patient would have been much more symptomatic.Another repeat ct/barium showed no leak, so the patient went on advance diet and went home after 2 weeks.The patient had retching/vomiting, so the tear might have gotten larger due to that.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

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: 8370943
• MDR Text Key: 137171111
• Report Number: 3006897778-2019-00001
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2019

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: 01/28/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 02/26/2019; 09/23/2019
• Supplement Dates FDA Received: 03/21/2019; 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR