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

Catalog Number S410GH/CNA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abdominal Pain (1685)

Event Date 02/13/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

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.

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®
• Type of Device: 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
• MDR Text Key: 332332191
• Report Number: 9615728-2024-00001
• Device Sequence Number: 1
• Product Code: NAJ
• UDI-Device Identifier: 00884450403402
• UDI-Public: 00884450403402
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S410GH/CNA
• Device Lot Number: X2588763_
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female