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

Catalog Number SO-2101

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

Patient Problems Abscess (1690); Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

Sterilization records were reviewed and were within specification.No additional infection complaints were received associated with this production lot of (b)(4) units released for distribution may 20, 2016.Physician believes the catheters or spaceoar needle must have gotten contaminated at time of procedure or during hdr treatment.Staff turnover in or has created new people with less familiar semi-sterile procedure.Potential for contamination with decreased familiarity of hdr procedure.Also the hospital had just changed their sterilization packaging for the hdr catheters to a new "bubble pack" and perhaps this new method for preparing the hdr catheters could have had a lapse in sterilization.Additionally it was noted the patient had a sub-standard hygiene and this could have increased the potential for this outcome.

Event Description

Physician called augmenix to request information on our historical infection rate associated with spaceoar.He had a patient with an active infection that he treated post high dose radiation (hdr) and spaceoar placement.His thoughts were that the infection was not directly related to spaceoar gel.One week after treatment-patient presented with transperineal pain.Medrol dose pack was prescribed and pain went away.Two weeks after treatment- patient re-presented with transperineal pain.Medrol dose pack prescribed a second time and pain went away.On (b)(6) 2016 - took mri and confirmed spaceoar hydrogel was between rectum and prostate.Rectal wall thickening is present on mri and hyper intense signal is hydrogel, not abscess.Patient was having persistent pain in the perineum which is worsening.Pain persistent and mildly elevated white blood count to 10.5.This elevated count thought to be due to the prescribed steroids.On (b)(6) 2016 - patient presents with white blood count elevated up to 17.Patient is given a contrast enhanced ct scan to check for rectal wall perforation.No perforation is observed.Urethrogram performed to confirm no fissures within urethra, none observed.Ct scan reveals some air collections between the prostate and the rectum and the area of the penile bulb region.Physician very concerned about infection.Oral antibiotics prescribed at this time are ciporo, flagil and bacterin.On (b)(6) 2016 - patients perineum pain is worsening.An additional ct scan is taken and the air collection diagnosed (b)(6) remains in place, no additional air seems present.White count is down from 17 to 14 today.Patient admitted and trans-perineal incision allowed for 20cc pus to be extracted.On (b)(6) 2016 - physician indicated that patient is doing well and asking to be discharged.They were keeping him a bit longer on iv fluids, meds, and monitor.

• Brand Name: SPACEOAR SYSTEM
• Type of Device: HYDROGEL SPACER
• Manufacturer (Section D): AUGMENIX, INC; 204 second avenue; waltham MA 02451
• Manufacturer (Section G): AUGMENIX, INC; 204 second avenue; waltham MA 02451
• Manufacturer Contact: james mayol ; 204 second avenue; waltham, MA 02451 ; 7819021665
• MDR Report Key: 6183158
• MDR Text Key: 62680620
• Report Number: 3008550999-2016-00001
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 0100864661000102
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2016
• Device Catalogue Number: SO-2101
• Device Lot Number: 07251601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2016
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 104