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

Model Number 00884450403204

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/22/2023

Event Type  Injury  

Event Description

The account alleges that during a transcatheter arterial embolization procedure for metastatic liver tumor transferred from the sigmoid colon, the patient experienced anaphylaxis.Epinephrine was administered and intubation performed.The physician stated that the patient had a history of allergy to contrast and stated the allergic reaction was more likely due to the contrast than the embolization.

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 medical device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record and complaint database for similar complaints for this lot could not be reviewed since no lot number was 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: 16492612
• MDR Text Key: 310770767
• Report Number: 9615728-2023-00001
• 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,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00884450403204
• Device Catalogue Number: S220GH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• 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): Required Intervention; Life Threatening