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

Model Number SV-2101

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/23/2024

Event Type  malfunction  

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 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 implanted during a spaceoar vue placement procedure on (b)(6) 2024.On (b)(6) 2024, the physician reported, that during a follow-up routine magnetic resonance imaging (mri), the patient complained of pelvic pain.During the imaging, the shape of the hydrogel looked unusual.It was suspected that some hydrogel might have gotten into the rectal wall.The procedure was performed under general anesthesia.Additionally, fiducial markers were placed transperineally prior to injection.On mri, the hydrogel seemed to indicate that the muscular was largely intact, but the gel was under the serosa.None of the hydrogels seemed to be coming close to the lumen.Due to the position of the hydrogel, it was deemed that it was safe to proceed with 28 fractions.The patient's pain subsided on its own.

• 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: 18976073
• MDR Text Key: 338584103
• Report Number: 2124215-2024-15925
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/02/2024
• Initial Date FDA Received: 03/25/2024
• 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 Age: 59 YR
• Patient Sex: Male