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

Model Number UNK-P-SPACEOAR

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date, (b)(6) 2021, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2021.Operator of the device was approximated to healthcare professional.The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on an unknown date.As of (b)(6) 2021 the patient had spaceoar treatment four weeks ago and was having problems after the procedure.The patient was brought to the emergency room by his wife.The patient's radiation treatment will be delayed for six weeks.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 12271811
• MDR Text Key: 264943886
• Report Number: 3005099803-2021-03977
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/03/2021

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: UNK-P-SPACEOAR
• Device Catalogue Number: UNK-P-SPACEOAR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/03/2021
• 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): Other