MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Catalog Number S620GH/JPA

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

Patient Problems Fever (1858); Micturition Urgency (1871); Fibrosis (3167)

Event Date 02/26/2017

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

The account reported that a uterine artery embolization was performed on (b)(6) 2017.On (b)(6) 2017 pyrexia, pollakiuria, painful micturition and low back pain developed.The next day the patient made an after-hours visit to the hospital.Pyelonephritis was diagnosed, and levofloxacin hydration was prescribed.Pyrexia repeatedly developed after the visit.On (b)(6) 2017, the patient visited the hospital again.Ultrasonography showed an improvement in hydronephrosis.Moreover, no findings suggestive of abscess formation was noted on emergency computed tomography.Follow-up observation for inflammatory reaction was performed.On (b)(6) 2017 myoma expulsion was noted.The patient pulled out the myoma with her own hands.On (b)(6) 2017 myoma expulsion was still noted.It also had a strange odor and no improvement was confirmed.The patient thus visited the hospital again with lower abdominal pain.The length of the myoma expelled outside the vagina was about 10 cm.Marked abdominal bloating was noted.The expelled myoma was removed as much as possible on an outpatient basis, but the removal was far from complete.Pyrexia developed again and the patient was urgently hospitalized.Blood culture yielded negative results.Administration of sulbactam/ampicillin (sbt/abpc) at 3g 3 time per day was initiated.On (b)(6) 2017 vaginal expulsion of a part of the myoma was noted and a part of the myoma was removed using cooper scissors and colposcope.No percussion pain was noted.Pyrexia started to develop again after the procedure.On (b)(6) 2017 persistent spike fever was noted.A discussion with the patient and her husband was held and a decision was made to perform total abdominal hysterectomy (tah).On (b)(6) 2017 (24 days after uae) semi-urgent tah, bilateral salpingectomy, and left cystectomy was performed.Hemodilution due to fluid therapy performed at the start of surgery resulted in decreased hemoglobin levels and transfusion of red cell concentrates (4 units) was performed.The surgery required 2 hours and 58 minutes to be completed.The amount of bleeding was 650 ml and the weight of the removed specimen was (b)(6).On (b)(6) 2017 (postoperative day 5) a drainage tube in the douglas' pouch was removed and antibiotic therapy was discontinued.On (b)(6) 2017 (postoperative day 10) no findings suggestive of infection were noted in the wounded area or abdomen and 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
• 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, ms, cqe, csqp ; 1600 west merit parkway; south jordan, UT 84095
• MDR Report Key: 6592931
• MDR Text Key: 76020851
• Report Number: 9615728-2017-00019
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S620GH/JPA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2017
• 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: 51 YR