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

Model Number SO-2101

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

Impact code f1001 is being used to capture the reportable issue of the aborted/canceled procedure.

Event Description

It was reported to boston scientific corporation that a spaceoar device was going to be used in a spaceoar implant procedure, performed with general anesthesia, on (b)(6) 2023.Additionally, the patient received fiducial markers.During the injection phase, the spaceoar device clogged.It was also reported that the diluent syringe was clogged; however, the accelerator syringe was not showing signs of clogging.The medical staff stated that they were getting an uneven push.It was noted that approximately 1cc of accelerator fluid was injected, but none of the diluent fluid seemed to be injected at all.As a result, the procedure was aborted.It was also noted that before the injection everything was normal and no human error was reported or witnessed, the kit was correctly assembled per the instructions for use (ifu).No adverse reactions or harm were reported to have occurred to the patient.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16300290
• MDR Text Key: 309017441
• Report Number: 3005099803-2023-00413
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: SO-2101
• Device Catalogue Number: SO-2101
• Device Lot Number: 0030054257
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male