MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Catalog Number S820GH/JPA

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

Patient Problems Fever (1858); Unspecified Infection (1930); Abnormal Vaginal Discharge (2123)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the complaint database and device history record could not be performed since the lot number was not provided.

Event Description

On (b)(6) 2016 a uterine artery embolization (uae) was performed.On (b)(6) 2016 the patient was discharged from hospital.On (b)(6) 2016 pyrexia and malodorous discharge developed.On (b)(6) 2016 the patient visited the outpatient department and started receiving oral administration of an antibiotic.However, no improvements in symptoms were noted.On (b)(6) 2016 the white blood cell (wbc) count and c-reactive protein (crp) level increased.The patient was thus hospitalized.Antibiotic therapy was initiated and continued until for one week.On (b)(6) 2016 laboratory data showed little improvement.Administration of fesin was initiated and continued until (b)(6) 2016 to improve anemia.Magnetic resonance imaging revealed production of intrauterine gas and urgent surgical procedure was considered necessary.Abdominal total hysterectomy (ath) was thus performed.Adona and transamin were administered for postoperative hemostasis.The patient made good progress after the procedure.On (b)(6) 2016 the patient was discharged from hospital.

• Brand Name: EMBOSPHERE MICROSPHERES
• Type of Device: MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations; paris nord 2; 383, rue de la belle etoile, 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL SA; parc des nations; paris nord 2; 383, rue de la belle etoile, 95700 ; FR 95700
• Manufacturer Contact: casey hughes ; 1600 w merit parkway; south jordan 84095 ; 8012081600
• MDR Report Key: 7275465
• MDR Text Key: 100234818
• Report Number: 9615728-2018-00001
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S820GH/JPA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• 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: 50 YR
• Patient Weight: 48