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

Model Number SV-2101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Constipation (3274)

Event Date 01/09/2024

Event Type  Injury  

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: patient code e2330 is being used to capture the reportable event of pain.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed on (b)(6) 2024.Post spaceoar placement, the patient complained about rectal pain, constipation and some burning sensation.The patient was treated with antibiotics and cortisone cream, additionally a computerized tomography (ct) scan was ordered.During examination, the patient appeared completely comfortable.Rectal exam showed the patient had a smooth rectum, submucosal prominence and no signs of ulceration or a fistula.There is no sign of inflammation or infection.Further review of the images revealed that the hydrogel is not in the rectal wall and appears to be correctly positioned.However, it did not conform to the shape of the rectum.Although slight indentation of the rectum was noted at one point in the midgland, the hydrogel extended laterally well beyond the rectum in both directions.It was indicated that the patient's radiation treatment has not yet started.

• Brand Name: SPACEOAR VUE 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: 18812825
• MDR Text Key: 336601073
• Report Number: 2124215-2024-10812
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182971
• 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: 02/29/2024

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
• Device Operator: Health Professional
• Device Model Number: SV-2101
• Device Catalogue Number: SV-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/29/2024
• 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 Outcome(s): Other
• Patient Sex: Male