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

Model Number SO-4101

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Pain (1994); Perforation (2001)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

Blocks 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 e172001 captures the reportable event of abscess.Imdrf patient code e231501 captures the reportable event of purulent discharge.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was used during a spaceoar vue implant procedure on (b)(6) 2023.The procedure was performed lumbar anesthesia.After the fourth day of radiotherapy, the patient began experiencing pain and had pus in the perineum.Therefore, it was suspected that in the location of the hydrogel was an abscess.A rectal perforation was suspected, and allergic reaction was noted.The patient underwent antibiotic treatment, and a surgical drain was performed.No further information has been obtained despite good faith efforts.

• Brand Name: SPACEOAR 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: 17726411
• MDR Text Key: 323150174
• Report Number: 3005099803-2023-04700
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181465
• 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: 09/11/2023

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: SO-4101
• Device Catalogue Number: SO-4101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/11/2023
• 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
• Patient Sex: Male