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

Catalog Number S420GH

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

Patient Problem Loss of Vision (2139)

Event Date 04/06/2023

Event Type  Injury  

Event Description

The account alleges that a patient experienced visual loss post an embolic procedure.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.

• 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: 16717267
• MDR Text Key: 313067649
• Report Number: 9615728-2023-00002
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: S420GH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability