MAUDE Adverse Event Report: INTERSCOPE, INC. ENDOROTOR; ENDOROTOR CATHETER

Catalog Number	3.2-EPR-EGD-F
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Hematemesis (4478)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that on (b)(6) 2022 a 75-year- old patient was undergoing an endoscopic resection for dysplasic barrett's esophagus.The physician resected 100% of the circumference of the lumen within the treatable segment.There were no issues reported during the procedure.Post-procedure, the patient began feeling pain and developed symptoms of hypothermia and hematemesis, twice.The patient was administered intravenous (iv) proton-pump inhibitors (ppis) to treat the symptoms.The patient then presented to the emergency unit 14 days from the procedure date.At the emergency unit, the patient was diagnosed with grade 3 dysphagia symptoms.The patient was re-hydrated and a feeding tube via percutaneous endoscopic gastrostomy (peg) was placed.The patient underwent an endoscopic dilation.A narrow and very short(< 1 cm) stricture was observed which resolved after 7 esophageal endoscopic dilation sessions.It was noted that the time of the incident, the patient was enrolled in an endobarret's study.Device manufacturing records were reviewed for indication relating to the complaint with no positive findings.Root cause was not able to be determined based on information provided, and the delayed onset of symptoms.Hematemesis is a known procedual risk in treatment of esophageal endoscopic resection.Bleeding during the procedure is not considered an adverse event of the protocol and can be managed endoscopically.Because an acute post procedure bleed that required intervention was not diagnosed hematemesis could be the result of any bleeding managed during the procedure.Based on available information there is no evidence to suggest there was a device related failure or direct causality to the hematemesis.Root cause for the dysphagia has a definite procedure causality but is a risk in circumferential endoscopic resection and not the result of a device failure.
Event or Problem Description
It was reported that on (b)(6) 2022 a 75-year- old patient was undergoing an endoscopic resection for dysplasic barrett's esophagus.The physician resected 100% of the circumference of the lumen within the treatable segment.There were no issues reported during the procedure.Post-procedure, the patient began feeling pain and developed symptoms of hypothermia and hematemesis, twice.The patient was administered intravenous (iv) proton-pump inhibitors (ppis) to treat the symptoms.The patient then presented to the emergency unit 14 days from the procedure date.At the emergency unit, the patient was diagnosed with grade 3 dysphagia symptoms.The patient was re-hydrated and a feeding tube via percutaneous endoscopic gastrostomy (peg) was placed.The patient underwent an endoscopic dilation.A narrow and very short(< 1 cm) stricture was observed which resolved after 7 esophageal endoscopic dilation sessions.It was noted that the time of the incident, the patient was enrolled in an endobarret's study.

• Brand Name: ENDOROTOR
• Common Device Name: ENDOROTOR CATHETER
• Manufacturer (Section D): INTERSCOPE, INC.; 200 commerce drive floor 2; northbridge MA 01534
• Manufacturer (Section G): INTERSCOPE, INC.; 200 commerce drive floor 2; northbridge 01534
• Manufacturer Contact: jeffery ryan ; 200 commerce drive floor 2; northbridge, MS 01534
• MDR Report Key: 17442757
• Report Number: 3011697028-2023-00024
• Device Sequence Number: 2597942
• Product Code: PTE
• UDI-Device Identifier: 00854172008155
• UDI-Public: 01008541720081551723022610210
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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: 02/16/2023
• Device Catalogue Number: 3.2-EPR-EGD-F
• Device Lot Number: 210216C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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
• Patient Sex: Unknown