MAUDE Adverse Event Report: AUGMENIX, INC. SPACEOAR; HYDROGEL SPACER

Catalog Number SO-2101

Device Problem Insufficient Information (3190)

Patient Problem Sudden Cardiac Death (2510)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, the patient underwent a procedure to implant spaceoar and ldr brachytherapy seeds.The patient was provided with 0.5mg ativan prior to the procedure and the procedure was performed under local anesthesia.During the procedure, visibility was limited so the implanting physician performed an enema to void the bowel of stool.The procedure appeared to go smoothly.The implanting physician aspirated to check for vascular involvement during the procedure and no blood was detected.Following the procedure, the patient complained of dizziness and nausea.The patient's energy began to diminish, and speech became incoherent.The patient then lost consciousness.Resuscitation efforts began, and the patient was transported to the hospital.The patient's wife informed the implanting physician that the patient was feeling nauseous and unwell prior to the procedure.The patient was placed on a ventilator upon arrival at the hospital.Echocardiogram showed evidence of pericardial effusion, but it is currently unknown if this was a result of chest compressions or an underlying condition.On (b)(6) 2019, the patient was disconnected from the ventilator and passed away.At this time, a death certificate and official cause of death is not available.The patient did not receive any post procedure imaging of the pelvic area.From the available information, the cause of the patient's death cannot be conclusively determined.

Event Description

It was reported that following a procedure to implant spaceoar and ldr seeds, the patient complained of dizziness and nausea.The patient subsequently lost consciousness and resuscitation efforts began.The patient was transported to the hospital where he later passed away.

• Brand Name: SPACEOAR
• Type of Device: HYDROGEL SPACER
• Manufacturer (Section D): AUGMENIX, INC.; 201 burlington rd.; bedford MA 01730
• Manufacturer (Section G): AUGMENIX, INC.; 201 burlington rd.; bedford MA 01730
• Manufacturer Contact: james mayol ; 201 burlington rd.; bedford, MA 01730 ; 7819021665
• MDR Report Key: 8413055
• MDR Text Key: 138554422
• Report Number: 3008550999-2019-00004
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN140030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2019

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 Catalogue Number: SO-2101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/12/2019
• 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): Death
• Patient Age: 74 YR
• Patient Weight: 82