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

Model Number SV-1010

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

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

Block 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 e1310 captures the reportable event of urinary tract infection.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure on (b)(6) 2023.Prophylactics antibiotics were administered.Three fiducial markers were placed before hydrogel injection.The procedure was performed under general anesthesia.The successful procedure was confirmed via ultrasound; no adverse events or device observations were noted.Then on (b)(6) 2024, the patient started radiation treatment delivered via linear accelerator (linac); 5 fractions were received from january (b)(6) 2024.The patient was admitted to the hospital on (b)(6) 2024 with epididymo-orchitis caused by a urinary tract infection (uti).The patient presented to the emergency department with bilateral scrotal swelling, pain, erythema, and subjective fevers that had been ongoing for two days.A urine culture test revealed the presence of e.Coli.A scrotal ultrasound suggested right-sided epididymo-orchitis and a reactive, somewhat complex right-sided hydrocele.Treatment included intravenous piptaz and analgesics.The patient was discharged on 16th february 2024, as was previously report, with a four-week course of po trimethoprim.The patient was readmitted to the hospital on (b)(6) 2024, with epididymo-orchitis and testicular pain.The patient started iv antibiotics and analgesics.A scrotal ultrasound was conducted again on (b)(6) 2024, similar to the one performed on (b)(6) 2024.The patient's treatment was changed from iv antibiotics to a one-month course of oral ciprofloxacin.The patient was discharged on (b)(6) 2024, when he was stable and no longer experiencing testicular pain.A follow-up appointment has been scheduled for six months from now.Boston scientific has been unable to obtain additional information despite good faith efforts.

Manufacturer Narrative

Additional information block b5 and h6 has been update with the additional information.Block 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 e1310 captures the reportable event of urinary tract infection.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure on (b)(6) 2023.Prophylactics antibiotics were administered.Three fiducial markers were placed before hydrogel injection.The procedure was performed under general anesthesia.The successful procedure was confirmed via ultrasound; no adverse events or device observations were noted.Then on (b)(6) 2024, the patient started radiation treatment delivered via linear accelerator (linac); 5 fractions were received from (b)(6) 2024, to (b)(6) 2024.The patient was admitted to the hospital on (b)(6) 2024 with epididymo-orchitis caused by a urinary tract infection (uti).The patient presented to the emergency department with bilateral scrotal swelling, pain, erythema, and subjective fevers that had been ongoing for two days.A urine culture test revealed the presence of e.Coli.A scrotal ultrasound suggested right-sided epididymo-orchitis and a reactive, somewhat complex right-sided hydrocele.Treatment included intravenous piptaz and analgesics.The patient was discharged on (b)(6) 2024, as was previously report, with a four-week course of po trimethoprim.The patient was readmitted to the hospital on (b)(6) 2024, with epididymo-orchitis and testicular pain.The patient started iv antibiotics and analgesics.A scrotal ultrasound was conducted again on (b)(6) 2024, similar to the one performed on (b)(6) 2024.The patient's treatment was changed from iv antibiotics to a one-month course of oral ciprofloxacin.The patient was discharged on (b)(6) 2024, when he was stable and no longer experiencing testicular pain.A follow-up appointment has been scheduled for six months from now.Boston scientific has been unable to obtain additional information despite good faith efforts.Additional information received on may 03, 2024: it was later reported that on (b)(6) 2024, the patient experienced a non-serious rectal bleeding, no medical actions were taken.The event was resolved on (b)(6) 2024.The relationship between the rectal bleeding and hydrogel study was report as possible related.

• 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
• MDR Report Key: 18881739
• MDR Text Key: 337404610
• Report Number: 2124215-2024-12091
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K182971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: SV-1010
• Device Catalogue Number: SV-1010
• Device Lot Number: 0029651237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male