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

Model Number SV-2101

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/13/2023

Event Type  Injury  

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 device code a1502 captures the reportable event gel misplaced - non vascular.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar placement procedure on (b)(6) 2023.The procedure was performed with local anesthesia.The patient reported experiencing lots of pain after the hydrogel placement.The hydrogel placement was seemed to be all around the prostate.The patient started with pain pills and steroids.The physician requests an additional physical exam.The patient is feeling better, and his symptoms has been reported as improved.The patient is planned for external beam radiation treatment, it's unknown if the radiation treatment was delayed due to this event.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar placement procedure on (b)(6) 2023.The procedure was performed with local anesthesia.The patient reported experiencing lots of pain after the hydrogel placement.The hydrogel placement was seemed to be all around the prostate.The patient started with pain pills and steroids.The physician requests an additional physical exam.The patient is feeling better, and his symptoms has been reported as improved.The patient is planned for external beam radiation treatment, it's unknown if the radiation treatment was delayed due to this event.Additional information received on january 12, 2024.It was further report that in the physical exam the patient had some focal perineum on exam, but nothing clearly abnormal.On computed tomography (ct) the hydrogel seemed to be infiltrated into the venous plexus surrounding the prostate.After an evaluation of the case, it was deemed that was safe to treat this patient.The patient had to go on hydrocodone for pain control.The pain was bad for 5 days the physician prescribed a dose of medrol, the pain was reported as resolved after this.

Manufacturer Narrative

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 device code a1502 captures the reportable event gel misplaced - non vascular.

• 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: 18508029
• MDR Text Key: 332880104
• Report Number: 2124215-2023-75120
• 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,Followup
• Report Date: 02/06/2024

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: 12/19/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/06/2024
• 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