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

Model Number	SO-2101
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
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 - vascular and 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.
Event or Problem Description
It was reported to boston scientific corporation that a spaceoar was used during a placement procedure performed on (b)(6) 2026.During the procedure, it looked like the gel moved towards the apex, most likely deposited anterior to denovillier's fascia, which allowed it to spread out bilaterally.Also, the lower needle tract might had let it spread to the penile bulb.A magnetic resonance imaging (mri) was performed, and it found that the hydrogel had spread near the prostate capsule to the left and the right posteriorly.Then, it gathers near the apex, and a small amount goes inferiorly near the penile bulb.Also, it appears to be hydrogel near both neurovascular bundles.Due to these findings, the physician will place a rectal balloon on the patient, because; there is basically no protection from the hydrogel.The patient is expected to start his radiation treatment soon.
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 - vascular and 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.Device evaluation: the device was not returned for analysis; therefore, a technical analysis could not be performed as it remains implanted.A review of the device history record (dhr) was performed.It was confirmed that this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations that could have contributed to the reported event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of gel found in unintended site-nonvascular was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.
Event or Problem Description
It was reported to boston scientific corporation that a spaceoar was used during a placement procedure performed on (b)(6) 2026.During the procedure, it looked like the gel moved towards the apex, most likely deposited anterior to denovillier's fascia, which allowed it to spread out bilaterally.Also, the lower needle tract might had let it spread to the penile bulb.A magnetic resonance imaging (mri) was performed, and it found that the hydrogel had spread near the prostate capsule to the left and the right posteriorly.Then, it gathers near the apex, and a small amount goes inferiorly near the penile bulb.Also, it appears to be hydrogel near both neurovascular bundles.Due to these findings, the physician will place a rectal balloon on the patient, because; there is basically no protection from the hydrogel.The patient is expected to start his radiation treatment soon.

• 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: 24645971
• Report Number: 2124215-2026-15408
• Device Sequence Number: 13313795
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: (01)00864661000102
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: SO-2101
• Device Catalogue Number: SO-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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/20/2026
• 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: Male