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

Model Number SO-2101

Device Problem Positioning Problem (3009)

Patient Problem Discomfort (2330)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as the best estimate based on information indicating that the placement occurred four months prior to this report.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.

Event Description

It was reported to boston scientific corporation that a spaceoar device was implanted during a placement procedure performed on an unknown date.It was reported that the patient experienced a rectal wall infiltration.The patient did not experience significant clinical symptoms other than a few days with rectal pressure.As a result, a computerized tomography (ct) scan and magnetic resonance imaging (mri) was required.The information suggests that the patient's radiation treatment was delayed.Additionally, it indicates that the placement occurred four months prior to this report.Boston scientific has been unable to obtain additional details, despite good faith efforts (gfes).

• Brand Name: SPACEOAR SYSTEM
• Type of Device: 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: 18636859
• MDR Text Key: 334543696
• Report Number: 2124215-2024-04102
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2024

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?: No
• Device Operator: 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
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male