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 Unspecified Infection (1930); Necrosis (1971); Pain (1994); Swelling/ Edema (4577)

Event Date 11/14/2023

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 patient code e2327 captures the reportable event of necrosis.Imdrf patient code e1906 captures the reportable event of infection.

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 procedure was performed with local anesthesia.The patient was on androgen deprivation therapy (adt) and received 27 fractions of intense moderate radiation treatment (imrt) on (b)(6) 2024.Then, the patient began complaining of perineal and scrotal pain.On exam, the patient had significant erythema and edema in the perineum and scrotum.Therefore, the patient was sent to the emergency room (er), where a computed tomography (ct) was performed.The imaging showed soft tissue edema; it was noted that it was malodorous.The ct showed air and subcutaneous necrotization.The patient was diagnosed with fournier's gangrene.The patient received several debridements in the er; they were able to save the patient's testicles; blood cultures were performed from surgical specimens; it was positive for bacteroides fragilis.It was noted that, "overall, the patient is in good health".

• 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: 18810564
• MDR Text Key: 336616618
• Report Number: 2124215-2024-10141
• 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: 02/04/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male