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

Model Number SV-1010

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

Patient Problems Micturition Urgency (1871); Urinary Frequency (2275)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e1318 captures the reportable event of urinary frequency.Imdrf patient code e1304 captures the reportable event of urinary urgency.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device implanted during a spaceoar vue placement procedure on (b)(6) 2023.Prophylactic antibiotics were administered prior to injection.The procedure was performed under local anesthesia, lidocaine and pentrox anesthetic.It was noted that the successful placement procedure was confirmed under ultrasound.No patient complications were reported, during the procedure.On (b)(6) 2023, prior to the placement procedure, the patient experienced non serious urinary urgency and renal and urinary disorder, nocturia.No medication was given to the patient this time.On december 11, 2023, the patient started his radiation treatment delivered via lineal accelerator (linac).Later on, december 15, 2023, 32 days after the placement procedure, the patient experienced a non-serious renal and urinary disorders and urinary urgency.The patient received medication.These events have been reported ongoing at the time of this report.The patient current condition is unknown.Boston scientific was unable to obtain additional information despite good faith efforts.

• 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: 18509260
• MDR Text Key: 332873275
• Report Number: 2124215-2023-75067
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K182971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2024

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-1010
• Device Catalogue Number: SV-1010
• Device Lot Number: 0031128276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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 Age: 74 YR
• Patient Sex: Male