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

Model Number SO-4101

Device Problem Positioning Problem (3009)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Ischemia (1942); Ulcer (2274)

Event Date 01/10/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spaceoar device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2022.Additionally fiducial markers were placed transperineally.The spaceoar was implanted, and the radiation treatment was completed.However, the patient complained of bloody stools.An endoscopy was performed, and it revealed a rectal ulcer.It was also reported that there were no inflammatory symptoms; therefore, the patient was followed up and was reported to be under observation.The physician stated that the spaceoar device may have been implanted into the rectum.In the physician's assessment, the ulcer occurred as a consequence of ischemia caused by the entry of the spaceoar into the rectum, and the cause of the bloody stools was related to the ulcer.The patient's outcome is unknown.

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Device code a1502 is being used to capture the reportable event of gel misplaced non-vascular.

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: device code a1502 is being used to capture the reportable event of gel misplaced non-vascular.Patient code e2314 is being used to capture the reportable event of fistula.Block h11: blocks b1, b2, b5, g1, h1, has been updated based on additional information received on october 31, 2023.

Event Description

It was reported to boston scientific corporation that a spaceoar device was implanted during a placement procedure performed under local anesthesia on (b)(6) 2022.Additionally fiducial markers were placed transperineally.The spaceoar was implanted, and the radiation treatment was completed.However, the patient complained of bloody stools.An endoscopy was performed, and it revealed a rectal ulcer.It was also reported that there were no inflammatory symptoms; therefore, the patient was followed up and was reported to be under observation.The physician stated that the spaceoar device may have been implanted into the rectum.In the physician's assessment, the ulcer occurred as a consequence of ischemia caused by the entry of the spaceoar into the rectum, and the cause of the bloody stools was related to the ulcer.The patient's outcome is unknown.Additional information received on october 31, 2023.It was reported that due to the ulcer, the patient was being monitored.The ulcer did not heal naturally on its own, and a rectal fistula was observed.Therefore, an endoscopic over the scope clip (otsc) procedure was performed.

• 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 ; 5086834015
• MDR Report Key: 16292708
• MDR Text Key: 308957668
• Report Number: 3005099803-2023-00411
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SO-4101
• Device Catalogue Number: SO-4101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/22/2023
• 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