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	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 01/01/2026, was chosen as the best estimate based on the date that the manufacturer became aware of the event 01/29/2026.Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: impact 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.
Event or Problem Description
It was reported to boston scientific corporation that a spaceoar was used during a placement procedure performed on an unknown date.During a magnetic resonance imaging (mri), it was noticed that there was a rectal wall invasion at the midgland area.There were no patient complications, the patient is reported to be asymptomatic.There was a delay on the patient's radiation treatment.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 01/01/2026, was chosen as the best estimate based on the date that the manufacturer became aware of the event 01/29/2026.Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: impact 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.Device evaluation: the device was not returned for analysis; the event could not be confirmed since it did not include a returned device or media review to identify any issue that could confirm the reported allegation.The device history record (dhr) review confirms that the accepted device met all manufacturing specifications.A labeling review was performed; the instructions for use (ifu) indicate that "under ultrasound guidance in the sagittal view, and with the needle tip at the prostate mid-gland, use a smooth, continuous injection technique to dispense the spaceoar vue hydrogel into the space between the prostate and rectal wall".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 during product risk analysis to support acceptable risk benefits for the product.Based on the reported information, a gel misplacement has been identified.Gel misplacements are understood to be primarily caused by the user having the needle in the incorrect location at the time of injection.Therefore, 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 an unknown date.During a magnetic resonance imaging (mri), it was noticed that there was a rectal wall invasion at the midgland area.There were no patient complications, the patient is reported to be asymptomatic.There was a delay on the patient's radiation treatment.

• 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: 24473411
• Report Number: 2124215-2026-11135
• Device Sequence Number: 10278103
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: (01)00864661000102
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K202224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/13/2026

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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/13/2026
• 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