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

Model Number	SO-2101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Pain (1994); Urinary Retention (2119)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a spaceoar device was implanted during a spaceoar placement procedure on late january.The procedure was performed with local anesthesia.Later, around three weeks later, the patient started radiation treatment, at the same time the patient started with urinary problems, a foley catheter was implanted, this event developed into pain in the pelvis and with urination.The radiation treatment finished on at the end of march.The patient's pain was worse and was spreading to his abdomen, therefore, the patient had a computed tomography (ct) scan that showed a fluid collection where the hydrogel was supposed to be, around 5cm around.Due to this event, the patient was prescribed with antibiotics for two weeks.The physician kept his watch on this patient and will considerer to drain the fluid.The patient current condition is unknown at the time of this report.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2024.Block d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient code e172001 captures the reportable event of abscess.Imdrf patient code e1309 captures the reportable event of urinary retention.Imdrf patient code e2330 captures the reportable event of pain.

• 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: 19237940
• Report Number: 2124215-2024-24961
• Device Sequence Number: 15489562
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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: 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): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male