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 Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Micturition Urgency (1871); Urinary Frequency (2275)

Event Date 09/01/2023

Event Type  Injury  

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 patient required a water tap enema twice prior to placement because they were full of stool.Post operation computed tomography (ct) was performed and showed the hydrogel in the correct location.The patient began experiencing vague abdominal symptoms, urgency, and frequency.A 5 cm peri rectal abscess in the area of the hydrogel placement formed and is displacing the spaceoar.The abscess pushes up the prostate posteriorly.The abscess was drained by transrectal ultrasound, 30cc of purulent material came out, and 7 days later it re accumulated in the same space.The patient was prescribed with ertapenem intra venous (iv) with a peripherally inserted central catheter (picc) line.The patient's physician used a transperineal pigtail drain, and the physician intends to check on the drain 10 days later.The drain will be removed if the abscess cavity closes, and the output lowered.The patient current condition was unknown at the time of this report.Radiation therapy has been delayed until the abscess heals.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as the best estimate based on the date that the manufacturer became aware of the event, september 07, 2023.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 e172001 captures the reportable event of abscess.Imdrf patient code e0506 captures the reportable event of bleeding.Imdrf patient code e2330 captures the reportable event of pain.

• 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: 17845363
• MDR Text Key: 324614408
• Report Number: 3005099803-2023-05115
• 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: 09/29/2023

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: 09/06/2023
• Initial Date FDA Received: 09/29/2023
• 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