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

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

Event Date 02/27/2015

Event Type  Injury  

Manufacturer Narrative

Nothing is expected to be returned for evaluation.Since the lot number was not provided, the device history record could not be reviewed for this lot.However complaint database was reviewed for similar issues, and no similar event was found.Merit medical/biosphere medical will continue to pay attention to the development of similar events.

Event Description

Primary disease: neuroendocrine tumour with metastasis to the liver.About 3 days after embolisation with the device, c-reactive protein level increased and slight fever was developed.Computed tomography was performed, showing liver abscess.Symptoms were developed about 3 days after the use of embosphere, so liver abscess was considered to be related to the device.

• Brand Name: EMBOSPHERE JICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; rossy-en-france ; FR
• Manufacturer Contact: alix fonlladosa ; parc des nationa - paris nord 2; 383, rue de la belle etoile; rossy en france 95 70-0 ; FR 95 700 ; 4817252
• MDR Report Key: 4808043
• MDR Text Key: 15368964
• Report Number: 9615728-2015-00006
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2015
• 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; Other
• Patient Age: 45 YR