MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE MICROSPHERES; AGENTS, EMBOLIC, FOR UFE

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Date 06/08/2012

Event Type  Injury  

Event Description

It was reported that a pt incurred impaired vision post uterine fibroid embolization (ufe) procedure.The manufacturer was made aware of this adverse event through the fda's medwatch program.No other information was provided or has been made available.

Manufacturer Narrative

Device evaluation: the suspect device is not expected to be returned for evaluation.The device history record and the complaint database could not be reviewed for lot specific information as no catalog or lot number was provided.Pma/510 (k) number is an estimate.Merit has received one complaint whereby the pt reported 'partial vision loss' post uterine fibroid embolization (ufe).Reference manufacturer report # 9615728-2013-00003 for specific information.This complaint was provided to the manufacturer through the fda medwatch program.Please reference attached copy of report received.Merit is unable to obtain additional information or determine a root cause without additional information.This complaint is unconfirmed.A follow up report will be submitted if additional information becomes available.

• Brand Name: EMBOSPHERE MICROSPHERES
• Type of Device: AGENTS, EMBOLIC, FOR UFE
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; roissy-en-france ; FR
• Manufacturer Contact: alix fonlladosa ; 383, rue de la belle etoile; parc des nations - paris nord 2; roissy en 95 70-0 ; FR 95 700 ; 481725
• MDR Report Key: 3599037
• MDR Text Key: 4169592
• Report Number: 9615728-2014-00001
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 01/15/2014

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability