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

Model Number SV-2101

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis of could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was used during a spaceoar vue and fiducials placement procedure performed on (b)(6) 2022.The procedure was performed under general anesthesia.During insertion, the gel started leaking out of the y-connector.The physician attempted to tighten the connection to the needle and the device continued to leak.Therefore, procedure could not be completed.There were no patient complications reported as a result of this event.The patient is reported to currently be asymptomatic.

• 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: 15177079
• MDR Text Key: 297491643
• Report Number: 3005099803-2022-04428
• Device Sequence Number: 1
• Product Code: OVB
• 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: 08/05/2022

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 Expiration Date: 09/29/2023
• Device Model Number: SV-2101
• Device Catalogue Number: SV-2101
• Device Lot Number: 0029219718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White