MAUDE Adverse Event Report: AUGMENIX, INC. SPACEOAR SYSTEM; ABSORBABLE PERIRECTAL SPACER

Model Number SO-2101

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

Patient Problems Dyspnea (1816); Nausea (1970); Discomfort (2330); No Code Available (3191)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was 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 on (b)(6) 2020 that spaceoar was implanted during a spaceoar implant procedure performed on (b)(6) 2020.Reportedly, the procedure was done under local anesthesia and fiducial markers were placed prior to spaceoar placement.According to the complainant, the physician noted that the patient was pale, slightly nauseous and breathing heavy post procedure.Intramuscular injection (im) of benadryl was administered and the patient's color improved.The patient was then transported to the hospital.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): AUGMENIX, INC.; 201 burlington road; bedford MA 01730
• Manufacturer (Section G): AUGMENIX, INC.; 201 burlington road; bedford MA 01730
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9676818
• MDR Text Key: 177983319
• Report Number: 3005099803-2020-00314
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2020

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 Expiration Date: 04/16/2021
• Device Model Number: SO-2101
• Device Catalogue Number: SO-2101
• Device Lot Number: 0005031901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• 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): Hospitalization