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

Model Number UNK-P-SPACEOAR

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/01/2022

Event Type  malfunction  

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.(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.

Event Description

It was reported to boston scientific corporation that a spaceoar device was used during a spaceoar placement procedure performed on an unknown date.Fiducial markers were placed during the same procedure.During injection, it felt firmer that usual to push the hydrogel.During planning magnetic resonance imaging (mri) review it was noticed that a small amount of the hydrogel was under the capsule at the apex.The remainder of the hydrogel appeared to have migrated around the prostate to the 1 to 3 o'clock position.The needle possibly nicked under the prostate capsule prior to injection.Boston scientific corporation has been unable to obtain additional information regarding this event, 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: 15089551
• MDR Text Key: 304526438
• Report Number: 3005099803-2022-04035
• 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: Physician
• Type of Report: Initial
• Report Date: 07/22/2022

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 Model Number: UNK-P-SPACEOAR
• Device Catalogue Number: UNK-P-SPACEOAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/22/2022
• 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 Age: 72 YR
• Patient Sex: Male