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

Model Number SO-4101

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)

Patient Problem Adhesion(s) (1695)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

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 attempted to be implanted during a spaceoar placement procedure performed (b)(6) 2021.The procedure was performed under general anesthesia.During the procedure, the kit clogged.The patient has anatomical adhesion between the prostate and rectum.The patient was already sedated and the procedure was cancelled.There were no patient complication reported as a result of this event.

• 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: 12214627
• MDR Text Key: 263141886
• Report Number: 3005099803-2021-03652
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2021

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: SO-4101
• Device Catalogue Number: SO-4101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/22/2021
• 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