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	Abscess (1690); Fever (1858); Unspecified Infection (1930); Pain (1994); Discomfort (2330)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, one week after the spaceoar vue placement procedure, the patient presented to the emergency room (er) with fever and rectal pain.Computed tomography (ct) showed a 7mm abscess surround/encapsulating hydrogel in pelvic region.The patient was reported to be undergoing evaluation and treated with antibiotics, a magnetic resonance imaging (mri) was planned.The physician reported that a drainage may be required.The physician reported an infection was the cause of the patient's symptoms, assessed it as related to the placement procedure.It was reported that the patient is currently recovering with no lingering issues; however, the radiation treatment has been delayed.
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 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 infection.Imdrf patient code (b)(6) captures the reportable event of abscess.Imdrf patient code (b)(6) captures the reportable event of fever.Imdrf patient code (b)(6) captures the reportable event of pain.

• 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; 500 commander shea boulevard MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50569005
• Report Number: 2124215-2026-46832
• Device Sequence Number: 13395147
• Product Code: OVB
• UDI-Device Identifier: 00864661000140
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/02/2026

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: 08/07/2026
• Initial Report FDA Received Date: 09/02/2026
• 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; Hospitalization
• Patient Sex: Unknown