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 Fever (1858); Unspecified Infection (1930); Pain (1994); Tachycardia (2095)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

D4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.H6: imdrf patient code (b)(6) captures the reportable event of fever.Imdrf patient code (b)(6) captures the reportable event of increased pulse rate.Imdrf patient code (b)(6) 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 in (b)(3) 2023.The procedure was performed with local anesthesia, after the placement the successful injection was confirmed via ultrasound.On (b)(3) 2023, the patient experienced a non-serious infection, increased pulse rate and rectal pain, it was also noted that after the procedure the patient had high temperature.The event of infection it was resolved with antibiotics and co-amoxiclav for management of the possible infection that at the same time helped with the increased pulse.The high temperature was addressed with medication for fever.The rectal pain was treated with ibuprofen.The patient current condition was unknown.However, the adverse events were reported as resolved on (b)(3)2023.

• 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: 18356165
• MDR Text Key: 330887341
• Report Number: 2124215-2023-69353
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2023

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 Expiration Date: 02/08/2024
• Device Model Number: SV-1010
• Device Catalogue Number: SV-1010
• Device Lot Number: 0030032176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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: 64 YR
• Patient Sex: Male