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

Model Number SV-1010

Device Problems Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problems Diarrhea (1811); Fistula (1862); Inflammation (1932); Perforation (2001); Urinary Frequency (2275); Fluid Discharge (2686)

Event Date 08/25/2023

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 e2114 captures the reportable event of perforation.Imdrf patient code e2326 captures the reportable event of inflammation.Imdrf patient code e2314 captures the reportable event of fistula.Imdrf device code a1502 captures the reportable event gel misplaced - non-vascular.Imdrf device code a04 captures the reportable event gel lasts too long.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue implant procedure on an unknown date.On (b)(6) 2022, the magnetic resonance imaging (mri) confirmed the placement of the spaceoar vue hydrogel.On, (b)(6) 2023, imaging showed that the spaceoar had significantly decreased in size with internal locules of gas, a focal protrusion and a possible communication with the anterior anorectum was also noted.On (b)(6) 2023, an mri of the pelvis and rectum was performed, the imaging showed a colon-vesical fistula.It was also noted that the device was related to the anorectal perforation and fistula.The hydrogel seen as currently inseparable from the membranous urethra on the exam.It was noted there was air tracking into the left seminal vesicle.The patient experienced liquid discharge, watery diarrhea from rectum when passing urine, mild rectal inflammation and cystitis.The urinary bladder was catheterized.The patient was noted to have fully recovered.

• 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: 17912743
• MDR Text Key: 325397327
• Report Number: 3005099803-2023-05368
• 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: 10/11/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SV-1010
• Device Catalogue Number: SV-1010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/11/2023
• 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