MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Catalog Number S420GH/JPA

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

Patient Problems Abdominal Pain (1685); Fever (1858); Unspecified Infection (1930); Necrosis (1971)

Event Date 07/23/2019

Event Type  Injury  

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 Description

The account alleges that on (b)(6) 2019 a uterine artery embolization [uae] procedure was successfully performed.The patient experienced a uterine myoma expulsion, developed an intrauterine infection and necrosis post uae.A resection of the uterus was performed on an unknown date.On (b)(6) 2019, the patient was recovering from uterine myoma expulsion and intrauterine infection.

Manufacturer Narrative

Additional information received from the account.

Event Description

Additional information received from the account: on (b)(6) 2019, at around 23:00, the patient, who was experiencing pyrexia and abdominal pain for 2 months, visited the reporter's hospital as taking analgesics did not lead to any improvement.When she visited, she was seen by a gynecologist, and the gynecologist identified a dark red discharge.A white tissue 8 cm in size at the opening of the uterus was noted.Ultrasonography identified a mass 11 cm in size.On (b)(6) 2019, the day after admission, contrast enhanced computed tomography demonstrated myoma necrosis, development of gas and partial prolapse into the vagina, leading to the above mentioned diagnoses.Treating with antibiotics was considered difficult, and total hysterectomy was thus performed the same day.Inflammation subsequently improved.On (b)(6) 2019, the patient was discharged from the 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
• MDR Report Key: 9092136
• MDR Text Key: 163377148
• Report Number: 9615728-2019-00009
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S420GH/JPA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 48