MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE MICROSPHERES

Model Number 500-700

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Necrosis (1971)

Event Date 01/30/2015

Event Type  Injury  

Event Description

Primary disease: haemangioma of liver.On (b)(6) 2014, initial hepatic embolization was performed preoperatively for a large haemangioma of the liver.On (b)(6) 2015, the haemangioma was not sufficiently shrunk, and a 2nd arterial embolization as thus performed.This time, the right hepatic artery (rha) and a4 branch (the medial branch of the left hepatic artery) were embolized with embosphere 500-700 um (using 3.8ml out of 20ml of the solvent prepared).As embolization was performed at the origin of rha, inflow of the spheres was also noted in the cystic artery, disrupting the blood flow at the fundus of the gallbladder.After embolization, abdominal pain persisted.On (b)(6) 2015, computer tomography was performed, showing necrosis of the fundus of the gallbladder.On the same day, cholecystectomy and resection of the haemangioma were performed concurrently due to a risk of rupture.On (b)(6) 2015, the patient recovered from gallbladder necrosis and was discharged.

Manufacturer Narrative

Results: device problems that occur during the performance, use or functioning of the device.Conclusions: device problems known and documented in the labeling (including both short or long term known complications or adverse reactions).(b)(4)/biosphere medical will continue to pay attention to the development of similar events.

• Brand Name: EMBOSPHERE MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; rossy-en-france ; FR
• Manufacturer Contact: alix fonlladosa ; parc de nations, paris; nord 2 383 rue de la belle; etolle rossy ch de gaulle cede ; FR ; 48172525
• MDR Report Key: 4808042
• MDR Text Key: 5892221
• Report Number: 9615728-2015-00008
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: 500-700
• Device Catalogue Number: S620GH
• Device Lot Number: X447276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 50