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

Model Number	SV-2101
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a spaceoar vue placement procedure was performed on (b)(6)2026.During the hydrodissection, the first attempt was not successful, an explanation of the correct method, the physician repositioned the needle several times in an attempted to achieve safe hydrodissection, upon the last attempt the physician felt comfortable moving forward the hydrogel injection.After 2 cc the physician felt resistance and could not push more hydrogel out of the system, the kit was removed ant was handed off to the nurse who confirmed that the kit clogged.The decision was to discontinue the procedure.The patient was under monitoring anesthesia care (mac) and was reported stable.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of procedure aborted.

• 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 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50946854
• Report Number: 2124215-2026-51862
• Device Sequence Number: 10429579
• Product Code: OVB
• UDI-Device Identifier: 00864661000140
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/30/2026

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: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• 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