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 Problem Abscess (1690)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 02/21/2024.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 e172001 captures the reportable event of abscess.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure on unknown date.The procedure was performed under general anesthesia.After the procedure, the patient developed an abscess.The patient was admitted to the hospital for further treatment.It was unknown if the patient was discharged; his current state of health was reported as unknown.

• 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: 18906185
• MDR Text Key: 337691119
• Report Number: 2124215-2024-13923
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000140
• UDI-Public: 00864661000140
• 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: 03/14/2024

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: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• 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): Hospitalization
• Patient Sex: Male