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 Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling/ Edema (4577)

Event Date 07/27/2023

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: imdrf patient code e2338 captures the reportable event of edema/swelling.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue implant procedure on (b)(6) 2023.Approximately two to three hours after the procedure was performed, the patient began to experience mild edema in his face and then presented with a rash.The patient went to emergency room (er) for further treatment.The patient was reported as "expected to fully recover." no further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue implant procedure on (b)(6) 2023.Approximately two to three hours after the procedure was performed, the patient began to experience mild edema in his face and then presented with a rash.The patient went to emergency room (er) for further treatment.The patient was reported as "expected to fully recover." no further information has been obtained despite good faith efforts.Additional information received on september 04, 2023.It was further reported the patient went to emergency room (er) a received epinephrine, benadryl and steroid pack.The patient was eventually discharged from the er with zyrtec, pepsid and epinephrine pen.The patient's symptoms edema and swelling were reported as caused by the fermagon shot caused the allergic reaction or antibiotics shot rocephin.It was reported that there were not previously allergic reactions to iodine that the patient had prior contrast.The patient symptoms were reported as resolved and his current condition was reported as "good".

Manufacturer Narrative

Additional information: block b5 has been update with the addition information received on september 04, 2023.Correction: block h6 impacted codes have been update with the addition information received on september 04, 2023.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 e2338 captures the reportable event of edema/swelling.

• 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: 17596098
• MDR Text Key: 321650058
• Report Number: 3005099803-2023-04323
• 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,Followup
• Report Date: 09/26/2023

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: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/26/2023
• 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
• Patient Sex: Male
• Patient Race: Black Or African American