MAUDE Adverse Event Report: CROSPON LTD ENDOFLIP; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number EF-325N

Device Problem Break (1069)

Patient Problems Bradycardia (1751); Perforation of Esophagus (2399); Radiation Exposure, Unintended (3164)

Event Date 01/29/2019

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 catheter was placed without a scope and the tip of the catheter went in to the cut in the esophagus when they did the poem procedure (peroral endoscopic myotomy).The physician performed an endoflip procedure, then performed a poem procedure.It was noted that this was the first poem procedure performed by the physician.Then, the physician passed the scope to examine the esophagus, and closed the mucosotomy with clips at 32cm.The scope was removed and placed the catheter again, blind.The physician experienced some tightness and did not see the gastroesophageal junction on the monitor.The flip was repositioned and experienced some resistance, so the physician removed the catheter and replaced the scope.That¿s when the physician found a mucosal tear at 42cm, and due to the myotomy performed, the tear was full thickness into the peritoneal cavity.The mucosal tear was closed with clips.The patient was then kept npo (nothing by mouth) and had an antibiotic for a few days, and slowly advanced to clear liquid diet.The patient underwent a barium swallow on post-procedure day 3 which did not show a leak but did show slow emptying into the stomach.On post-procedure day 4, the patient had symptomatic bradycardia and had to get a pacemaker.The patient underwent a ct scan to see if there were any hematomas or collections around the esophagus that could have been impinging on the heart, but the ct scan was normal.The patient went home in stable condition on post-procedure day 8.The physician felt like the soft tip of the cathet er was too flexible, that it actually bent and allowed the more rigid catheter to lead, which was a risk for perforation.The physician was trained to place the catheter blind, which was the recommendation and was advised to follow the catheter with the scope in unique cases, like poem procedures, where mucosotomies and myotomies have been performed and weakens the structure of the esophagus.The physician stated that will now follow the catheter with the scope and place it under direct vision for all future poems.

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: ENDOFLIP
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK
• MDR Report Key: 8386950
• MDR Text Key: 137716245
• Report Number: 3006897778-2019-00002
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• PMA/PMN Number: K160725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EF-325N
• Device Catalogue Number: EF-325N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention