MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOGOLD MICROSPHERES

Catalog Number S620EG

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

Patient Problems Foreign Body Reaction (1868); Patient Problem/Medical Problem (2688)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

The instruction for use of the device states that " because of the significant complications of misembolization, extreme caution should be used for any procedures involving the extracranial circulation encompassing the head and neck, and the physician should carefully weigh the potential benefits of using embolization against the risks and potential complications of the procedure.These complications can include blindness, hearing loss, loss of smell, paralysis and death." device is a permanent implant.

Event Description

Severe epistaxis and embolisation with the device on (b)(6) 2016 and severe pain related by patient - patient came back on (b)(6) 2016 for severe pain, trismus and small subcutaneous nodular formations.

• Brand Name: EMBOGOLD MICROSPHERES
• Type of Device: EMBOGOLD MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; roissy en france, france 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL; parc des nations, paris nord 2; 383, rue de la belle etoile; roissy en france, france 95700 FR; FR 95700 FR
• Manufacturer Contact: alix fonlladosa ; parc des nations paris nord 2; 383, rue de la belle etoile; roissy en france 95700 ; 0148172529
• MDR Report Key: 6221175
• MDR Text Key: 63815166
• Report Number: 9615728-2016-00013
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: S620EG
• Device Lot Number: X971240-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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