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 Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 08/16/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during spaceoar vue placement procedure on (b)(6) 2023.After the procedure, the patient developed shortness of breath and urticaria.The patient was sent to the emergency room and admitted overnight, where was treated with steroids and antihistamine.The patient's symptoms of shortness of breath improved, but the urticaria continued for approximately one day.No further information has been obtained despite good faith effort.

Manufacturer Narrative

Blocks 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 e0402 captures the reportable event of allergic reaction.Imdrf patient code e0717 captures the reportable event of dyspnea.

• 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: 18088265
• MDR Text Key: 327567680
• Report Number: 3005099803-2023-05831
• 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: 11/07/2023

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: 10/12/2023
• Initial Date FDA Received: 11/07/2023
• 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): Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White