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

Model Number	SV-2101
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a spaceoar vue was used during a placement procedure on (b)(6)2026, under local anesthesia.During hydrodisection, saline was observed in the rectum.Needle repositioning was instructed; however, the instructions were not followed, and the hydrogel was suspected to be injected in the rectum.There were no patient complications reported, the radiation therapy moved forward.
Additional Manufacturer Narrative
Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: device code a150202 is being used to capture the reportable event of gel found in unintended site - nonvascular.Block h11: 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.

• 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: 50693708
• Report Number: 2124215-2026-48182
• Device Sequence Number: 15874274
• Product Code: OVB
• UDI-Device Identifier: 00864661000140
• UDI-Public: (01)00864661000140
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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
• 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: 08/12/2026
• Initial Report FDA Received Date: 09/09/2026
• 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
• Patient Sex: Unknown