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

Model Number	SO-2101
Medical Device Problem Codes	Material Integrity Problem (2978); Positioning Problem (3009)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blockb3: the exact date of the event is unknown.The provided event date, 05/01/2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 05/22/2023.Blockd4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Blockh6: device code a1502 captures the reportable event of gel misplacement non-vascular.Device code a04 captures the reportable event of gel lasts too long.
Event or Problem Description
It was reported that the patient had the spaceoar hydrogel placement procedure six months ago.The device is still presents in the patient; additionally, an infiltration of the hydrogel into the rectal wall occurred.The patient's current condition remains unknown at the time of this report.
Additional Manufacturer Narrative
Additional information block b5 and h6 have been updated with the additional information.Correction block h6 imdrf patient code has been update with e2403.Blockb3: the exact date of the event is unknown.The provided event date, 05/01/2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 05/22/2023.Blockd4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Blockh6: device code a1502 captures the reportable event of gel misplacement non-vascular.Device code a04 captures the reportable event of gel lasts too long.
Event or Problem Description
It was reported that the patient had the hydrogel placement procedure six months ago, the device still presents in the patient, additional this has been complicated due to an infiltration of the hydrogel into the rectal wall.The patient current condition remains unknown at the time of this report.Additional information it was further reported that the patient's radiation treatment was delayed leading to the additional use of eligard and magnetic resonance imaging (mri) treatments.

• 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: 19543108
• Report Number: 2124215-2024-34632
• Device Sequence Number: 15355144
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 07/16/2024

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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/16/2024
• 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 Age: 66 YR
• Patient Sex: Unknown