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 Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907)

Event Date 04/27/2023

Event Type  Injury  

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: patient code e0402 captures the reportable event of allergic reaction.Patient code e0602 captures the reportable event of cardiac arrect.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue implant procedure performed on (b)(6) 2023.Fiducial markers were placed transperineally prior to the implant and the procedure was performed under general anesthesia.A few minutes after the procedure, when they put the patient's legs down, the patient experienced an allergic reaction/anaphylaxis also referred to as anaphylactic shock.The event was addressed by the staff with administration of epinephrine and cardiopulmonary resuscitation (cpr).The patient was also rushed to the hospital where they were admitted.The patient was discharged from the hospital on an unspecified date.The patient's symptoms resolved, and they had fully recovered.The patient's implanting physician did not know what caused the reaction.The patient was planned for external beam radiation; however, it was not specified if their treatment had occurred or yet begun.

• 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: 17131164
• MDR Text Key: 317206446
• Report Number: 3005099803-2023-03109
• 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
• Report Date: 06/14/2023

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: 05/25/2023
• Initial Date FDA Received: 06/14/2023
• 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; Hospitalization
• Patient Sex: Male