MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM; ABSORBABLE PERIRECTAL SPACER

Model Number SV-2101

Device Problem Positioning Problem (3009)

Patient Problems Inflammation (1932); Pain (1994); Urinary Frequency (2275); Dysuria (2684); Urinary Incontinence (4572)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was used during a spaceoar vue and fiducials placement procedure performed on (b)(6) 2022.The radiation treatment uses conventional fractionation, 44 fractions.During the procedure, the physician had a lot of trouble getting the plane.The patient complained of pain, dysuria, dribbling and frequent urination.The procedure was completed successfully.When the images from the planning computerized tomography (ct) scan were reviewed, there was no evidence of gel near the rectal wall but all of the gel appears to be within the posterior part of the prostate as a small ball that is likely compressing the urethra.The patient has been started on double flomax.The radiation treatment has been postponed for 4 months to allow the inflammation to reduce.The patient's current condition is reported to be stable.

• Brand Name: SPACEOAR VUE SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15561972
• MDR Text Key: 306006383
• Report Number: 3005099803-2022-05805
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SV-2101
• Device Catalogue Number: SV-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/07/2022
• 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 Sex: Male