MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Model Number	00884450403440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that post-uterine artery embolization (uae), the patient developed a perimetritic infection.The patient was treated for a 8.4×11×13 cm interstitial myoma with extensive endometrial contact and discharged to home 3 days post-uae.Approximately one month after the procedure, the patient presented with lower abdominal pain and pyrexia.Perimetritis was diagnosed and antibiotic therapy was administered.Myoma expulsion was noted two days later when it prolapsed from the vagina and was removed.At the time of this report, the patient is one year post-uae, remains asymptomatic, and the uterine was reported to have been successfully preserved.

• Brand Name: EMBOSPHERE MICROSPHERES
• Common Device Name: MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• MDR Report Key: 9713755
• Report Number: 9615728-2020-00002
• Device Sequence Number: 3422519
• Product Code: HCG
• UDI-Device Identifier: 00884450403440
• UDI-Public: 00884450403440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: 00884450403440
• Device Catalogue Number: S620GH/JPA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR