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

Model Number SO-2101

Device Problem Material Integrity Problem (2978)

Patient Problems Diarrhea (1811); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that a hydrogel spacer was implanted on (b)(6) 2023.After a routine follow-up, a computerized axial tomography scan and magnetic resonance imaging revealed that the hydrogel was still in the patient's anatomy after 10 months from the placement.The patient experienced a change in his bowel habits, reported as mainly flat-shaped waste.In addition, the patient also experienced diarrhea.The patient was referred to a gastroenterologist, who did not recommend a colonoscopy.

Manufacturer Narrative

The exact date of the event is unknown.The provided event date, march 01, 2024, was chosen as the best estimate based on the date when the patient reported to receive the follow-up scans in march 2024.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Device code a04 is being used to capture the reportable event of gel lasts too long.

• 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: 19102300
• MDR Text Key: 340457716
• Report Number: 2124215-2024-21543
• 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: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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
• 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: 03/21/2024
• Initial Date FDA Received: 04/12/2024
• 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: 55 YR
• Patient Sex: Male