MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC CARTRIDGE,20 FASTENERS, ,SEROSAFUSE FASTENER CARTRID; ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Catalog Number	R2175
Medical Device Problem Codes	Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Perforation of Esophagus (2399); Fluid Discharge (2686)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports that several days post-tif procedure, the physician noticed a female in-patient's blood pressure was elevated.The physician performed additional tests including a ct scan and an endoscopy, and nothing seemed abnormal at the time.The physician decided to bring the patient back to surgery to see if he could identify a suspected fluid leak.During the procedure, the physician noted that the abdomen was filled with gastric juice, and gi bubbling was identified along the fastener line.The physician deployed a self-expandable stent for additional support on (b)(6) 2024 and the gastric mucosa leak was successfully cauterized.The physician states that the transoral reconstructive device and the fastener cartridge both performed as intended.No device malfunctions were noted during this procedure.The physician is not sure what caused the gastric mucosa leak.The patient has fully recovered and tolerated the procedure well.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device will not be returning for engineering evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned, or the lot number identified, the investigation will be reopened.

• Brand Name: CARTRIDGE,20 FASTENERS, ,SEROSAFUSE FASTENER CARTRID
• Common Device Name: ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21129208
• Report Number: 1721504-2025-00002
• Device Sequence Number: 6957797
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 810275014011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: R2175
• 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: 12/16/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Life Threatening
• Patient Sex: Female