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

Model Number SV-1010

Device Problem Positioning Problem (3009)

Patient Problems Urinary Retention (2119); Urinary Frequency (2275); Dysuria (2684); Fluid Discharge (2686)

Event Date 05/22/2023

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 device code a1502 captures the reportable event gel misplaced - non-vascular.Imdrf patient code e2315 captures the reportable event of fluid 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 under local anesthesia.The hydrogel was successfully injected and was confirmed via ultrasound.The patient started radiation treatment with radiotherapy delivery via linear accelerator (linac).The patient completed 5 fractions that were administrated from (b)(6) 2023.On (b)(6) 2023 the patient experienced dysuria and urinary retention that was reported as not device or procedure related.On (b)(6) 2023, the patient experienced voiding the hydrogel during urination, that required medication.The event was resolved the same day.The relationship between the spaceoar vue and the event was reported as possibly related.The relationship between the event and the injection procedure and hydro dissection was reported as possible related.The patient current condition was unknown at the time of this report.

Manufacturer Narrative

Additional information block d4 has been update with the new information received respectively on november 28, 2023.Additional information block b5 has been update with the new information received respectively on october 06, 2023, and october 12, 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 device code a1502 captures the reportable event gel misplaced - non-vascular.Imdrf patient code e2315 captures the reportable event of fluid discharge.

Event Description

It was reported to boston scientific corporation that a space oar vue device was used during a space oar vue implant procedure on (b)(6) 2023.The procedure was performed under local anesthesia.The hydrogel was successfully injected and was confirmed via ultrasound.The patient started radiation treatment with radiotherapy delivery via linear accelerator (linac).The patient completed 5 fractions that were administrated from (b)(6) 2023.On (b)(6) 2023 the patient experienced dysuria and urinary retention that was reported as not device or procedure related.On (b)(6) 2023, the patient experienced voiding the hydrogel during urination, that required medication.The event was resolved the same day.The relationship between the space oar vue and the event was reported as possibly related.The relationship between the event and the injection procedure and hydro dissection was reported as possible related.The patient current condition was unknown at the time of this report.Additional information received on october 06, 2023.It was further reported the event is possible related to an error during the implanting the device.However, it was noted that the health care facility was unable to clarify if the voiding material was space oar hydrogel.The health care facility was unable to quantify the amount of hydrogel in the intended location.Additional information received on october 12, 2023.Later on, october 11, 2023, it was reported the spacer only covered base of the prostate, therefore the space from by the hydrogel was considered "poor".

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 under local anesthesia.The hydrogel was successfully injected and was confirmed via ultrasound.The patient started radiation treatment with radiotherapy delivery via linear accelerator (linac).The patient completed 5 fractions that were administrated from (b)(6)2023, to (b)(6), 2023.On (b)(6), 2023 the patient experienced dysuria and urinary retention that was reported as not device or procedure related.On (b)(6) 2023, the patient experienced voiding the hydrogel during urination, that required medication.The event was resolved the same day.The relationship between the spaceoar vue and the event was reported as possibly related.The relationship between the event and the injection procedure and hydro dissection was reported as possible related.The patient current condition was unknown at the time of this report.Additional information received on october 06, 2023.It was further reported the event is possible related to an error during the implanting the device.However, it was noted that the health care facility was unable to clarify if the voiding material was spaceoar hydrogel.The health care facility was unable to quantify the amount of hydrogel in the intended location.Additional information received on october 12, 2023.Later on, (b)(6) 2023, it was reported the spacer only covered base of the prostate, therefore the space from by the hydrogel was considered "poor".

Manufacturer Narrative

Additional information: block b5 has been update with the new information received respectively on october 06, 2023, and october 12, 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 device code a1502 captures the reportable event gel misplaced - non-vascular.Imdrf patient code e2315 captures the reportable event of fluid discharge.

Manufacturer Narrative

Additional information block b5 and h6 has been update with the new information received respectively on january 19, 2024.Additional information block d4 has been update with the new information received respectively on november 28, 2023.Additional information block b5 has been update with the new information received respectively on october 06, 2023, and october 12, 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 device code a1502 captures the reportable event gel misplaced - non-vascular.Imdrf patient code e2315 captures the reportable event of fluid 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 under local anesthesia.The hydrogel was successfully injected and was confirmed via ultrasound.The patient started radiation treatment with radiotherapy delivery via linear accelerator (linac).The patient completed 5 fractions that were administrated from (b)(6) 2023, to (b)(6) 2023.On (b)(6) 2023 the patient experienced dysuria and urinary retention that was reported as not device or procedure related.On (b)(6) 2023, the patient experienced voiding the hydrogel during urination, that required medication.The event was resolved the same day.The relationship between the spaceoar vue and the event was reported as possibly related.The relationship between the event and the injection procedure and hydro dissection was reported as possible related.The patient current condition was unknown at the time of this report.Additional information received on october 06, 2023 it was further reported the event is possible related to an error during the implanting the device.However, it was noted that the health care facility was unable to clarify if the voiding material was spaceoar hydrogel.The health care facility was unable to quantify the amount of hydrogel in the intended location.Additional information received on october 12, 2023 later on, (b)(6) 2023, it was reported the spacer only covered base of the prostate, therefore the space from by the hydrogel was considered "poor".Additional information received on january 19, 2024 it was also report that the patient complaint of dysuria and mild urinary retention and increased urinary frequency 3 hours after device insertion.These events were resolved by the next day.The relationship between the device and the event was report as not related.These events were report as resolved, except by urinary frequency that was report as ongoing.

• 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 ; 5086834015
• MDR Report Key: 17840590
• MDR Text Key: 324550384
• Report Number: 3005099803-2023-05113
• 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,Followup,Followup,Followup
• Report Date: 02/09/2024

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 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: Not provided
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/06/2023; Not provided; 01/19/2024
• Supplement Dates FDA Received: 10/31/2023; 12/21/2023; 02/09/2024
• 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: 66 YR
• Patient Sex: Male