MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SpaceOAR VUE¿ System - 10mL; Absorbable perirectal spacer

Model Number	SV-2101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Inflammation (1932); Pain (1994); Discomfort (2330)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a follow up after the spaceoar vue placement procedure, the patient received hydrogel 6 months ago and proceed with radiation therapy with no issues, then the patient started experiencing severe pain the rectal area with bowel movements that got worse at the point that was unable to go to work.The patient was sent to a colorectal surgeon who scoped him and found a mass on the left side of the rectum that was biopsied and called as nonmalignant, additionally the computed tomography (ct) showed a slight inflammation in the rectal area.The patient was treated with rectal hydrocortisone, preparation h, proctofoam and a carafate suppository.Additionally, pain has been treated with narcotics as nothing else was helpful.The relationship between the device and the event has been reported as unknown.It was also reported that the patient was scheduled for a magnetic resonance imaging (mri).
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block b3: the exact date of the event is unknown.The provided event date, 08/01/2026, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 08/05/2026.Block d4:h4 the event was unable to provide the lot number of the device implanted.Therefore, there is not information related with device manufacturer day.Block h6: imdrf patient code (b)(6) captures the reportable event of pain.Imdrf patient code (b)(6) captures the reportable event of inflammation.Imdrf patient code (b)(6) captures the reportable event of discomfort.Imdrf patient code (b)(6) captures the reportable event of diarrhea.

• Brand Name: SpaceOAR VUE¿ System - 10mL
• Common Device Name: 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50515529
• Report Number: 2124215-2026-46494
• Device Sequence Number: 15796681
• Product Code: OVB
• UDI-Device Identifier: 00864661000140
• UDI-Public: (01)00864661000140
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K182971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/31/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown