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

Model Number	SO-2101
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
After the hydrogel placement, there was a suspicion of rectal wall infiltration.During simulation, the hydrogel was not visible, prompting a magnetic resonance imaging (mri) scan.The mri revealed potential infiltration of the anterior rectal wall with hydrogel at the midgland.Additionally, the patient has diverticulitis in the sigmoid colon.Upon further evaluation of the mri, one slice showed approximately 1 cm of hydrogel beneath the rectal wall, with a reasonable amount of muscularis behind it.Another slice indicated about 2-3 mm of hydrogel close to the mucosa, which was the only slice with hydrogel near the mucosa.The remaining hydrogel appeared to be primarily within the prostate capsule on the right posterolateral side and in the venous plexus extending up to the right internal iliac.
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 a1502 is being used to capture the reportable event of gel misplaced vascular and non-vascular.

• 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: 20398662
• Report Number: 2124215-2024-61857
• Device Sequence Number: 3492551
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K181465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/08/2024

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: 09/12/2024
• Initial Report FDA Received Date: 10/08/2024
• 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