MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK EMBOZENE¿ MICROSPHERES; AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS

Model Number 01-0301-04002-07

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

Patient Problems Headache (1880); Pain (1994)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the patient experienced headaches and claudication.The patient underwent an embolization of the right and left internal maxillary arteries using 400um embozene¿ microspheres in (b)(6) 2018.In (b)(6) 2018, the patient developed headaches on bilateral hemicrania predominantly on the left side, claudication of the jaw, and induration of the temporal right artery with hyperesthesia of bilateral scalp.The physician prescribed corticotherapy of 0.7mg / kg for one month allowing a regression of all symptoms.Ten days after discontinuation of corticosteroids the headaches reappeared.

Manufacturer Narrative

Describe event or problem, name prefix, last name, occupation: updated.(b)(4).

Event Description

It was further reported that the patient's headaches were caused by giant cell arteritis and possibly related to the embozene spheres.The headaches began a few days post embolization procedure.The patient did not have a prior history of headaches.The patient is in good condition under corticotherapy.

• Brand Name: EMBOZENE¿ MICROSPHERES
• Type of Device: AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7655912
• MDR Text Key: 112995776
• Report Number: 2134265-2018-05873
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• PMA/PMN Number: K141209
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2020
• Device Model Number: 01-0301-04002-07
• Device Catalogue Number: 14020-S1
• Device Lot Number: 21148118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention