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 Fever (1858); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/13/2023

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Patient code e2338 is being used to capture the reportable event of edema.Patient code e2330 is being used to capture the reportable event of pain.Patient code e2402 is being used to capture the positive blood culture/bacteremia.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed on (b)(6) 2022.Additionally, fiducial markers were placed.On (b)(6) 2023 the patient presented with fever and rectal pain.The patient received a urine culture which was negative for infections.Therefore, the physician decided to perform a computerized tomography (ct) scan.However, over that weekend, the patient went to the emergency department (ed) and was admitted due to increased pain and fevers.The patient's white blood cell (wbc) count was elevated at 12,000 to 14,000.The blood culture turned positive for b.Fragilis.A ct scan done by the ed apparently showed fluid around the spaceoar vue implant.In the physician's assessment, the scan did not look like an abscess, instead, it looked like clear fluid.He also did not see any spaceoar vue in the rectal wall.The patient was treated with intravenous (iv) antibiotics since his admission to the ed, and he was reported to be improving.The patient's pain and fever were down, although his white blood cell count was reported to had not yet decreased.It was also reported that the plan is to keep the patient under antibiotics treatment and avoid a drainage for now.If it is necessary, the physician will attempt a drainage himself.It was also planned to get a magnetic resonance imaging (mri) without contrast, to determine if the hydrogel is in the rectum.Boston scientific has been unable to obtain additional details, despite good faith efforts (gfes).

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16350009
• MDR Text Key: 309261292
• Report Number: 3005099803-2023-00448
• 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: 02/10/2023

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: 01/17/2023
• Initial Date FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male