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	Bacterial Infection (1735); Pain (1994); Pleural Effusion (2010); Pleural Empyema (4459); Hyponatremia (4494)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The device was discarded at the account.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 later, the investigation will be reopened.
Event or Problem Description
The account alleges that a hhr and a tif procedure were both performed on a female patient (b)(6) 2024.The patient presented in the ed on (b)(6) 2024 with back pain and a large pleural effusion, which looked to be an empyema / infection.The patient complained of back pain a few days earlier during a follow-up appointment, but the physician believed that the back pain was unrelated to the tif procedure.Lab work completed in the ed revealed hyponatremia and a ct procedure was performed confirming that the patient did not have an esophageal perforation.A thoracentesis was successfully performed for the effusion.The physician had a follow-up appointment with the patient on (b)(6) 2024, the physician stated that the female patient looked "good." the patient is still in the hospital recovering from the pleural effusion and is waiting for a follow-up visit from the physician.

• 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 84094
• 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: 20614863
• Report Number: 1721504-2024-00069
• Device Sequence Number: 7453518
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 810275014011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/11/2024

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
• 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: 10/11/2024
• Initial Report FDA Received Date: 11/05/2024
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female