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

Model Number SV-2101

Device Problems Defective Device (2588); Positioning Problem (3009); Migration (4003)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Urinary Frequency (2275); Fluid Discharge (2686)

Event Date 06/23/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf patient code e1308 captures the reportable event of urinary frequency.Imdrf patient code e2330 captures the reportable event of pain.Imdrf device code a1502 captures the reportable event gel misplaced - non vascular.

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 with the local anesthesia.Fiducial markers were placed prior the hydrogel injection.The patient received his first fraction of radiation on (b)(6) 2023.On cone beam computed tomography (cbct), the axial slice showed the hydrogel might be outside of the rectal wall.On (b)(6) 2023, the patient complained of pain and frequency when urinating.Therefore, the patient was prescribed with flomax, ibuprofen and prophylactic antibiotics.On (b)(6) 2023, the patient stated that he had some blood in stool.That could be related to the patient's, medical history of hemorrhoids.On (b)(6) 2023, the hydrogel was clearly seen in place prior to treatment.On (b)(6) 2023, the hydrogel was seen to have migrated into the rectum before treatment that day.It was noted that the patient did not complain of any symptoms on (b)(6) 2023.The patient's cbct appeared to show that the gel was no longer in the usual place and had made its way into the lumen of the rectum.On (b)(6) 2023, the patient did not complain of blood or pain.Before treatment orient was imaged and the hydrogel was not seen.It was expected that the patient passed the hydrogel through stool.The relationship between the hydrogel and symptoms was reported as unknown.It was reported that the patient was planned for 28 fractions and was doing well.At the time of this reported the patient was completing his course of treatment.

• 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: 17741519
• MDR Text Key: 323350674
• Report Number: 3005099803-2023-04754
• 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: 09/13/2023

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
• Device Lot Number: 0031718429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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: 69 YR
• Patient Sex: Male