MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA BIOSPHERE EMBOSPHERES

Catalog Number S220GH/JPA

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

Patient Problems Eye Injury (1845); Visual Disturbances (2140)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that on (b)(6) 2016 the patient underwent a pre-operative embolization procedure.Embolization particles were injected into the right middle meningeal artery.Right eye pain and visual impairment were noted.Imaging of the right internal carotid artery was performed, and central retinal artery occlusion was diagnosed as a result.The patient was sent to the department of ophthalmology and received eye massage and anterior chamber puncture.Treatment was performed with continuous drip infusion of heparin (1500 u/day) from (b)(6) 2018 and dexart (dexamethasone sodium phosphate, 3.3 mg/day) was administered on (b)(6) 2016 - (b)(6) 2016.On (b)(6) 2016, right visual impairment persisted.The scheduled tumorectomy was postponed and the patient was discharged to home.On (b)(6) 2016 the patient was hospitalized again.On (b)(6) 2016 a resection of intracranial tumor was performed.On (b)(6) 2016, the patient was discharged home still experiencing right visual impairment.

• Brand Name: BIOSPHERE EMBOSPHERES
• Type of Device: EMBOSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; 95700 ; FR 95700
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 7938222
• MDR Text Key: 122825728
• Report Number: 9615728-2018-00002
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S220GH/JPA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 69 YR