MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOZENE MICROSPHERES; EMBOLIC DEVICE

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

Patient Problems Unspecified Infection (1930); Urinary Retention (2119); Insufficient Information (4580)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: article publication date used.Initial reporter facility name: (b)(6).Hidalgo, d.Salvador, et al."prostatic artery embolization treatment for patients with benign prostatic hyperplasia who are permanent urinary catheter users ineligible for de-obstructive surgery." actas urologicas espanolas (english edition) 45.7 (2021): 481-485.

Event Description

It was reported via a journal article that patient complications occurred.Abstract introduction: benign prostatic hyperplasia is considered the most frequent cause of lower urinary tract symptoms.Urinary catheterization is the emergency treatment for patients with urinary retention and surgery is indicated in patients refractory to medical treatment.There is a group of people with important comorbidities that make them ineligible for surgery.Prostatic arterial embolization (pae) could be presented as a safe and effective alternative to achieve bladder emptying and spontaneous urination, thus avoiding permanent urinary catheterization in patients with significant comorbidities that represent a contraindication for surgery.In this retrospective study, we evaluated the efficacy of pae in patients with permanent urinary catheterization who are ineligible for surgical treatment.Material and methods: retrospective study of 26 patients with permanent urinary catheter who underwent prostatic embolization.Demographic and clinical data (age, use of anticoagulation, prostate volume, length of hospital stay, unilateral or bilateral embolization), charlson comorbidity index evaluation and clavien-dindo classification for procedural complications were reviewed.Successful removal of permanent urinary catheter was analyzed at one month after the procedure.Results: a total of 26 patients were included in the review.The median age was 85 years with a median prostate volume of 90 ml.A charlson comorbidity score above 7 was obtained in 88.5% of the subjects.Only one patient had one clavien-dindo iii complication.Of the 26 subjects, 17 (65.4%) had spontaneous micturition and a postvoid residual lower than 100 ml at one month post procedure.Overall, catheter removal was achieved in 19 out of 26 subjects (73.1%).

• Brand Name: EMBOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15176707
• MDR Text Key: 297356464
• Report Number: 2134265-2022-08387
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other