MAUDE Adverse Event Report: MERIT MEDICAL, INC - ROISSY EMBOSPHERE®; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

Catalog Number	S410GH/CNA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges post a bilateral uterine artery embolization procedure the patient experienced severe postoperative abdominal pain, which required oral non-steroidal anti-inflammatory drugs, pteridine intramural injection, and morphine subcutaneous injection for pain relief.After above treatment, abdominal pain was gradually relieved.No additional information available.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Abdominal pain is one of the most frequently anticipated post procedure complications listed in the product's instruction for use known as "post-embolization syndrome.This anticipated complication has already been identified in the product's risk management file and the current assessment still adequate.
Additional Manufacturer Narrative
The suspect device is not expected to return for 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 later, the investigation will be reopened.

• Brand Name: EMBOSPHERE®
• Common Device Name: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): MERIT MEDICAL, INC - ROISSY; bat. a- parc des nations; 383 rue de la belle etoile; roissy charles de gaulle, cedex 95958 ; FR 95958
• Manufacturer (Section G): MERIT MEDICAL, INC - ROISSY; bat. a- parc des nations; 383 rue de la belle etoile; roissy charles de gaulle, cedex 95958 ; FR 95958
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 18466527
• Report Number: 9615728-2024-00001
• Device Sequence Number: 2984100
• Product Code: NAJ
• UDI-Device Identifier: 00884450403402
• UDI-Public: 00884450403402
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K021397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2023

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: 01/13/2026
• Device Catalogue Number: S410GH/CNA
• Device Lot Number: X2588763_
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 01/19/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/24/2024; 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female