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

Model Number UNK-P-SPACEOAR

Device Problem Material Integrity Problem (2978)

Patient Problems Abscess (1690); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a spaceoar device was implanted during a spaceoar placement procedure on an unknown date.It was noted that the hydrogel lasted over two years.The patient experienced an abscess that required treatment and recurrent bowel issues.Boston scientific has been unable to obtain additional information regarding this event, despite good faith efforts.

Manufacturer Narrative

The exact date of the event is unknown.The provided event date, (b)(6) 2022, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2022.The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Operator of device was estimated as health care professional based on the event details.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 14795759
• MDR Text Key: 295036842
• Report Number: 3005099803-2022-03483
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 06/23/2022

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: UNK-P-SPACEOAR
• Device Catalogue Number: UNK-P-SPACEOAR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention