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

Model Number	SO-2101
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 06/01/2025, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 06/19/2025.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 a1502 is being used to capture the reportable event of gel misplaced non-vascular.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 that a patient underwent a spaceoar placement procedure.During the procedure, the physician, with a resident present, placed a spaceoar classic device.Notably, the sphincter was observed to be unusually high, prompting the physician to adjust the needle placement to target the base and seminal vesicles.However, a subsequent computerized tomography (ct) simulation revealed that some of the hydrogel had inadvertently been injected into the prostate.Post-operatively, the patient experienced urinary difficulties, leading to urinary retention, necessitating the insertion of a catheter.A post-void residual (pvr) test showed a significant volume of 250cc.A recent magnetic resonance imaging (mri) revealed that approximately 99% of the gel has migrated to the bulbar urethra, below the level of the gu diaphragm, with very little remaining in the prostate area.
Event or Problem Description
It was reported that a patient underwent a spaceoar placement procedure.During the procedure, the physician, with a resident present, placed a spaceoar classic device.Notably, the sphincter was observed to be unusually high, prompting the physician to adjust the needle placement to target the base and seminal vesicles.However, a subsequent computerized tomography (ct) simulation revealed that some of the hydrogel had inadvertently been injected into the prostate.Post-operatively, the patient experienced urinary difficulties, leading to urinary retention, necessitating the insertion of a catheter.A post-void residual (pvr) test showed a significant volume of 250cc.A recent magnetic resonance imaging (mri) revealed that approximately 99% of the gel has migrated to the bulbar urethra, below the level of the gu diaphragm, with very little remaining in the prostate area.
Additional Manufacturer Narrative
Correction to block b2 outcomes attrib to adv event and d4 model and catalog number.Block b3: the exact date of the event is unknown.The provided event date, 06/01/2025, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 06/19/2025.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 a1502 is being used to capture the reportable event of gel misplaced non-vascular.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.

• 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: 22543548
• Report Number: 2124215-2025-48165
• Device Sequence Number: 12876433
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: (01)00864661000102
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: JA
• 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): 09/03/2025

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?: 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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/03/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown