MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-14 for SPACEOAR SYSTEM SO-2101 manufactured by Augmenix, Inc..
[178332302]
The complainant was unable to provide the suspect device lot number. Therefore, the expiration and device manufacture dates are unknown. (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.
Patient Sequence No: 1, Text Type: N, H10
[178332303]
It was reported to boston scientific corporation on december 17, 2019 that spaceoar was implanted between the prostate and anterior rectal wall during a spaceoar placement procedure performed on (b)(6) 2019. Reportedly, the procedure was done under local anesthesia and there were no issues noted during spaceoar placement. However, it was reported that the procedure took a long time and they needed a few extra sticks in order to correctly place the gold markers. According to the complainant, after the procedure, the patient tried to urinate before leaving the hospital but was unable to do so. The patient also declined to take cipro, an antibiotic administered by the hospital. Reportedly, the night of (b)(6) 2019, the patient went to the emergency room (er) for retention per the recommendation of the physician's assistant. At the er, the patient's white blood cell (wbc) count was elevated. The wbc count dropped back to a normal level after a few days of treatment. The patient's platelet count was normal. On (b)(6) 2019, a computerized tomography (ct) scan was performed in the er. A linear tract of extraluminal air between the rectum and prostate gland and additional fluid density was observed, which was reported to be expected after hydrogel implantation. On (b)(6) 2019, another ct scan was performed. The ct scan revealed no evidence of active bleeding. The ct scan showed that the internal mesenteric artery (ima) was occluded. There was a small bowel obstruction with dilation of the proximal jejunum. Increased fat stranding near sigmoid colon, which may represent colitis, was also observed. On (b)(6) 2019, a magnetic resonance imaging (mri) scan was also performed. A small amount of ill-defined fluid between the anterior wall of rectum and posterior prostate was observed. No rim-enhancing drainable collections were observed in the pelvis. There were signs of devitalization along the right lateral wall of the rectum and posterior prostate as well as in the intervening soft tissues. Continued small bowel obstruction and mild distention of the sigmoid colon were observed. Per the mri report, the spaceoar was placed correctly. On (b)(6) 2019, it was reported that the patient had urinary issues. A colonoscopy was performed and did not show any bowel issues. As of (b)(6) 2019, the patient had a diverting ostomy and it is unknown if the patient is still hospitalized. The patient has not received his stereotactic body radiation treatment yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00021 |
| MDR Report Key | 9586105 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-14 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | AUGMENIX, INC. |
| Manufacturer Street | 201 BURLINGTON ROAD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACEOAR SYSTEM |
| Generic Name | ABSORBABLE PERIRECTAL SPACER |
| Product Code | OVB |
| Date Received | 2020-01-14 |
| Model Number | SO-2101 |
| Catalog Number | SO-2101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AUGMENIX, INC. |
| Manufacturer Address | 201 BURLINGTON ROAD BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-14 |