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 Micturition Urgency (1871); Incontinence (1928); Pain (1994); Tissue Damage (2104); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

No event date was provided, therefore an approximate date of (b)(6) 2019 was used as the event date based on the event comments of "in december." the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.(b)(4).The device has been 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 january 10, 2020 that spaceoar was implanted during a spaceoar placement procedure performed in (b)(6) 2019.Reportedly, the procedure was done under local anesthesia and there were no issues noted during spaceoar placement.According to the complainant, in december 2019, the patient experienced pain, urinary urgency, urinary frequency, and incontinence.In the physician's assessment the patient's symptoms were related to the spaceoar device.A colonoscopy was performed and a sinus tract was noted.Medication was provided to treat the urinary urgency and urinary frequency.A procedure was performed that was intended to reduce side effects and improve quality of life.As of (b)(6) 2020, the patient is under disability due to his symptoms.

Manufacturer Narrative

No event date was provided, therefore an approximate date of (b)(6) 2019 was used as the event date based on the event comments of "in (b)(6)." blocks d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Block h6 (patient codes): patient code 1994 captures the reportable patient event of pain.Block h6 (evaluation conclusion codes): conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h11: block h6 (patient codes) has been updated.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that spaceoar was implanted during a spaceoar placement procedure performed in (b)(6) 2019.Reportedly, the procedure was done under local anesthesia and there were no issues noted during spaceoar placement.According to the complainant, in (b)(6) 2019, the patient experienced pain, urinary urgency, urinary frequency, and incontinence.In the physician's assessment the patient's symptoms were related to the spaceoar device.A colonoscopy was performed and a sinus tract was noted.Medication was provided to treat the urinary urgency and urinary frequency.A procedure was performed that was intended to reduce side effects and improve quality of life.As of (b)(6) 2020, the patient is under disability due to his symptoms.

• Brand Name: SPACEOAR SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): AUGMENIX, INC.; 201 burlington road; bedford MA 01730
• MDR Report Key: 9661172
• MDR Text Key: 177644172
• Report Number: 3005099803-2020-00279
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• 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,Followup
• Report Date: 03/02/2020

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 Model Number: SO-2101
• Device Catalogue Number: SO-2101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other