MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Catalog Number V820GH

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

Patient Problems Anemia (1706); Chest Pain (1776); Intermenstrual Bleeding (2665); Patient Problem/Medical Problem (2688)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

A follow up will be submitted upon completion of the investigation.Device is a permanent implant.

Event Description

The account alleges that the patient presented with significant post-abortion hemorrhaging, hypoxemia and medial thoracic chest pain.The patient was diagnosed with a ruptured uterine arteriovenous malformation and an emergent embolization of the patient's trophoblastic tissue bilaterally was performed.During embolic administration the patient continued to experience chest pain.The procedure was stopped for administration of basic life support and resuscitation by the code team.The patient was transferred to an intensive care unit for recovery.The patient received intravenous blood transfusions in the unit.

Manufacturer Narrative

Additional information was received from the account.The patient has totally recovered from this incident.

• Brand Name: EMBOSPHERE MICROSPHERES
• Type of Device: EMBOSPHERE 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 95700
• Manufacturer Contact: casey hugues, ms, cqe ; 1600 merit parkway; south jordan, ut, 84095 ; 8013164932
• MDR Report Key: 6342762
• MDR Text Key: 67802255
• Report Number: 9615728-2017-00001
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• 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: V820GH
• Device Lot Number: X971247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2016
• 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; Life Threatening; Required Intervention