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 Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Fluid Discharge (2686); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/03/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure on (b)(6) 2023.The patient received radiation treatment without problem.Four months after the procedure, on (b)(6) 2024, the patient had a fall on his buttocks that caused trauma.Since then, the patient has experienced increased tenesmus, pain, small bowel movements, and clear rectal drainage.There were no signs that suggested infection, like fever or chills.During a rectal exam a mass was noted in the anterior of the rectal wall that protruded into the upper canal and rectum.The mucosa was noted smooth.The physician did an ultrasound, and there was a darker signal in the area; it was suspected it was blood around the hydrogel.Therefore, the physician planned to drain the fluid around the hydrogel, by placing a needle.At the time of this report, the patient's condition was unknown.

Manufacturer Narrative

Block d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2315 captures the reportable event of mucosa discharge.Imdrf patient code e2506 captures the reportable event of hemorrhage.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf patient code e1605 captures the reportable event of tenesmus.Imdrf patient code e1007 captures the reportable event of constipation.

• 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: 19130990
• MDR Text Key: 340447008
• Report Number: 2124215-2024-22250
• 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: 04/17/2024

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: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• 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): Required Intervention
• Patient Sex: Male