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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an unknown spaceoar device was implanted during a spaceoar placement procedure on an unknown date.Per social media it was reported that the patient had an anaphylactic reaction during spaceoar placement procedure.Due to the anaphylactic reaction the patient coded for two minutes and was then resuscitated successfully.Boston scientific corporation has been unable to obtain additional information regarding this event, despite good faith efforts.

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 is being used to capture the reportable event of hypersensitivity/allergic reaction.

Event Description

It was reported to boston scientific corporation that an unknown spaceoar device was implanted during a spaceoar placement procedure on an unknown date.Per social media it was reported that the patient had an anaphylactic reaction during spaceoar placement procedure.Due to the anaphylactic reaction the patient coded for two minutes and was then resuscitated successfully.Boston scientific corporation has been unable to obtain additional information regarding this event, despite good faith efforts.

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 is being used to capture the reportable event of hypersensitivity/allergic reaction.Block h10 correction: additional information was received on january 18, 2024, indicating that the event reported under this report (mfr report number 2124215-2023-75114) is a duplicate of a previously reported event under mfr report number 3005099803-2022-06169.

• Brand Name: SPACEOAR 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: 18460607
• MDR Text Key: 332258646
• Report Number: 2124215-2023-75114
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 02/08/2024
• 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): Required Intervention; Life Threatening