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

Model Number SV-2101

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423)

Patient Problems Hypersensitivity/Allergic reaction (1907); Chills (2191)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number, therefore, the manufacture date and expiration date are unknown.Patient code e0402 was used to capture the reportable event allergic reaction.

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 monitored anesthesia care (mac) and local anesthesia, specifically lidocaine injection.During the injection, the kit reportedly clogged in the y-connector.It was noted the physician potentially paused during injection.The y-connector was purged of hydrogel with saline, and the physician was able to complete the procedure with the same kit.Following the procedure, the patient went to the emergency room (er) due to an allergic reaction.It was reported that the patient had experienced symptoms of chills and shaking approximately one to one and a half hours post implant procedure.The patient was admitted to the hospital.The patient was reported to be "doing better" by 8 o'clock in the morning on (b)(6) 2023.Boston scientific corporation has been unable to obtain additional information regarding this event, despite good faith efforts.

• 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: 16610769
• MDR Text Key: 311953122
• Report Number: 3005099803-2023-01255
• 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: 03/24/2023

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?: 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: 02/28/2023
• Initial Date FDA Received: 03/24/2023
• 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): Hospitalization
• Patient Sex: Male
• Patient Race: White