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); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Shock (2072); Vomiting (2144); Dizziness (2194); Loss of consciousness (2418); Confusion/ Disorientation (2553); Syncope/Fainting (4411)

Event Date 10/27/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2023.Post spaceoar vue implantation the patient experienced an allergic reaction.The patient exhibited the following symptoms: vomiting, difficult to communicate, hypotension, loss of consciousness, difficulty breathing, paleness, dizziness, nausea, low blood pressure, and he was disoriented.The patient did not report any prior allergic reactions.The patient was treated with oxygen and benadryl, and the patient's symptoms were resolved.An ambulance was called to transfer the patient to the nearest emergency room for further evaluation and management.The physician's assessment suggests a potential allergic response to the polyethylene glycol (peg) or iodine.It was indicated that the patient completed his treatment satisfactorily and is free of danger.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e0402 is being used to capture the reportable event of allergic reaction.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e0402 is being used to capture the reportable event of allergic reaction.Block h11: blocks b5 and d4 were corrected.Block h6 (patient codes) was updated and corrected based on additional information received on march 06, 2024.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2023.Post spaceoar vue implantation the patient experienced an allergic reaction.The patient exhibited the following symptoms: vomiting, difficult to communicate, hypotension, loss of consciousness, difficulty breathing, paleness, dizziness, nausea, low blood pressure, and he was disoriented.The patient did not report any prior allergic reactions.The patient was treated with oxygen and benadryl, and the patient's symptoms were resolved.An ambulance was called to transfer the patient to the nearest emergency room for further evaluation and management.The physician's assessment suggests a potential allergic response to the polyethylene glycol (peg) or iodine.It was indicated that the patient completed his treatment satisfactorily and is free of danger.

• 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: 18818237
• MDR Text Key: 336739986
• Report Number: 2124215-2024-11322
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000140
• UDI-Public: 00864661000140
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/28/2024

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: 02/07/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/28/2024
• 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 Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male