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

Catalog Number	R2275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Perforation of Esophagus (2399)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The device was discarded at the account.The complaint could not be confirmed and the root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The customer reports during a hiatal hernia [hh] repair followed by a transoral intragastric fundoplication [tif].During the hhr procedure, the physician dilated the patient using an over-the-wire dilator [60f] device, and while no obvious resistance was noted, upon inspection by the endoscope, there was tearing noted in the esophagus caused by the inflation balloon.It was not deemed to be significant enough to abort the tif procedure however the tearing was observed throughout a significant portion of the lower esophagus.The tif procedure was completed with 4 firings in the posterior aspect, 3 firings in the anterior, and 3 firings in the greater curve area to complete a 285° fundiplication.No problems/issues were noted during the tif procedure.Post-tif procedure the physician ordered an egd.The physician noted a suspicious area toward the posterior aspect of the repaired valve.Looking at the inside view of the gej, the suspicious area could be a perforation.The physician confirmed the perforation and placed a clip in the suspected area along with four additional clips that were placed to address the perforation/tearing of the gej.The patient was stented and is doing well.No evidence of a device malfunction.The patient was kept overnight for continued observation.

• Brand Name: SEROSAFUSE IMPLANTABLE FASTENER KIT
• 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: bryson heaton rn ; 1600 merit parkway; south jordan, UT 84094 ; 8012531600
• MDR Report Key: 20616268
• Report Number: 1721504-2024-00074
• Device Sequence Number: 18348137
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 810275014011
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K240879
• 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): 10/16/2024

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 Catalogue Number: R2275
• Device Lot Number: 403721
• 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: 10/16/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown