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

Model Number	UNK-P-SPACEOAR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific became aware that a spaceoar hydrogel system was used in the article title "when the rectal protection barrier causes complications: recognizing spacer-induced rectal fistula" written by hamza almusabeh of the article et al.The article presented the case of a patient who underwent spaceoar hydrogel for radiation, the patient presented to the hospital with hematochezia for 2 weeks.A computed tomography (ct) demonstrated no evidence of active hemorrhage.Subsequent colonoscopy revealed a deep mucosal defect located 1 cm proximal to the dentate line, consistent with a fistulous.A clip was successfully placed to close the fistula tract.At the follow up, there were no evidence of bleeding.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Labeling review was performed; there is no evidence the device was improperly used per the ifu.A risk review was completed and confirmed that the events are documented.These events have been accounted during product risk analysis to support acceptable risk benefits for the product.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.Based on the findings this investigation was assigned to known inherent risk of device.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.Blocks d4 and h4: the complainant was unable to report the upn/lot number; therefore, the manufacture date and expiration date are unknown.Block g2: almusabeh, h., wright, w., & pervez, a.(2025).When the rectal protection barrier causes complications: recognizing spacer-induced rectal fistula.Acg case reports journal, 12, e01938.Https://doi.Org/10.14309/cr.Block h6: imdrf patient code e2314 captures the reportable event of fistula.Imdrf patient code e0506 captures the reportable event of bleeding.Imdrf patient code e2326 captures the reportable event of inflammation.

• 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 CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24742507
• Report Number: 2124215-2026-17527
• Device Sequence Number: 8759458
• Product Code: OVB
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: UNK-P-SPACEOAR
• Device Catalogue Number: UNK-P-SPACEOAR
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/31/2026
• 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
• Patient Age: 78 YR
• Patient Sex: Male