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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Ulcer (2274)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blocks d4 and h4: the article did not provide associated lot numbers; therefore, the manufacture date and expiration date are unknown.Block h6: patient code (b)(6) is being used to capture the reportable event of fistula.Patient code (b)(6) is being used to capture the reportable event of ulcer.Patient code (b)(6) is being used to capture the reportable event of abscess.Block g2: jack c.Millot, adithya balasubramanian, laurenchew, gal wald, camilo arenas-gallo, edward zhang, jacob mccann, leo d.Dreyfuss, stephen rhodes, patrick lewicki, angela y.Jia, nicholas g.Zaorsky and jonathan e.Shoag, utilization, acute complications, and delays in treatment associated with rectal spacers for prostate cancer radiotherapy, urology, (2025) doi:https://doi.Org/10.1016/j.Urology.2025.06.070.Block h11: detailed product information was not provided to bsc.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.
Event or Problem Description
Boston scientific corporation became aware of multiple events involving a spaceoar hydrogel device, through the article utilization, acute complications, and delays in treatment associated with rectal spacers for prostate cancer radiotherapy by jack millot,.Et al.It was reported that the spaceoar hydrogel was associated with several acute complications occurring after device placement but prior to initiation of radiation therapy.Documented adverse events included genitourinary complications as well as gastrointestinal and rectal complications including rectal ulcer, rectal abscess requiring drainage, rectourethral fistula, and rectal fistula.Severe gastrointestinal complications such as rectourethral fistula, rectal ulcer, and abscess were considered directly related to device usage.The adverse events resulted in clinical interventions including abscess drainage.Clinically, these complications led to delays in initiating radiation therapy, and a subset of patients not proceeding to radiation at all following spacer placement.The relationship between the complications and device usage was considered directly related for gastrointestinal injuries.

• Brand Name: SPACEOAR SYSTEM
• 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: 22702158
• Report Number: 2124215-2025-52855
• Device Sequence Number: 14954253
• Product Code: OVB
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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
• 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: 07/08/2025
• Initial Report FDA Received Date: 08/04/2025
• 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: Male