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 Abscess (1690); Pain (1994); Urinary Frequency (2275); Unspecified Kidney or Urinary Problem (4503)

Event Date 05/01/2023

Event Type  Injury  

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, (b)(6) 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: patient code (b)(6) captures the reportable event of abscess.Patient code (b)(6) captures the reportable event of urinary frequency.Patient code (b)(6) captures the reportable event of pain.

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.After the procedure the patient was reported to be doing "ok".The patient started radiation treatment, but on the first day one of the three visicoils seemed to have shifted.The patient's anatomy kept changing.Therefore, the patient's simulation imaging was repeated.Then after three weeks of treatment the patient started to get abdominal pain and went in for a scan that showed the hydrogel was surrounded by a large fluid collection suggestive of a pelvic abscess.Computed tomography (ct) indicated possible tract to rectum.A colorectal surgery did a sigmoidoscopy, the imaging did not show anything in the rectum indicating a fistula.The patient experienced severe thickening of urinary bladder.The physician reported his concerning regarding a cystitis.The patient physician decided not to drain it and prescribed him antibiotics.It was suggested to the patient's physician to drain the active abscess and if is not possible to drain, then the patient may need a surgical excision.The patient reported that "he felt so ill to go outside his house".It was also reported the patient was doing "poorly" at the time of this report.No further information has been obtained despite good faith efforts.

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.After the procedure the patient was reported to be doing "ok".The patient started radiation treatment, but on the first day one of the three visicoils seemed to have shifted.The patient's anatomy kept changing.Therefore, the patient's simulation imaging was repeated.Then after three weeks of treatment the patient started to get abdominal pain and went in for a scan that showed the hydrogel was surrounded by a large fluid collection suggestive of a pelvic abscess.Computed tomography (ct) indicated possible tract to rectum.A colorectal surgery did a sigmoidoscopy, the imaging did not show anything in the rectum indicating a fistula.The patient experienced severe thickening of urinary bladder.The physician reported his concerning regarding a cystitis.The patient physician decided not to drain it and prescribed him antibiotics.It was suggested to the patient's physician to drain the active abscess and if is not possible to drain, then the patient may need a surgical excision.The patient reported that "he felt so ill to go outside his house".It was also reported the patient was doing "poorly" at the time of this report.No further information has been obtained despite good faith efforts.Additional information received on june 22, 2023.It was further reported that the procedure was performed under local anesthesia, one day in (b)(6) 2023.

Manufacturer Narrative

Additional information block b5 has been updated based on additional information received june 22, 2023.Block b3: the exact date of the event is unknown.The provided event date, may 01, 2023, was chosen as the best estimate based on the date that the manufacturer became aware of the event, may 30, 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: patient code e172001 captures the reportable event of abscess.Patient code e1311 captures the reportable event of unspecific kidney or urinary problem.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: 17175885
• MDR Text Key: 317633324
• Report Number: 3005099803-2023-03274
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00086461000140
• UDI-Public: 0086461000140
• 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,Followup
• Report Date: 07/12/2023

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: 05/30/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/12/2023
• 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 Age: 68 YR
• Patient Sex: Male