MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-03 for ADVANTA SLIDER GDS 22114 manufactured by Atrium Medical.
[129301571]
On completion of the investigation a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[129301572]
During the implant of an arterio-venous graft, the clinician noticed some foreign substance on the graft.
Patient Sequence No: 1, Text Type: D, B5
[133363092]
Analysis: the device was not returned. The details of the complaint indicate that the graft had foreign matter on the surface. Based on the image provided it is difficult to determine the presence of foreign matter. Conclusion: based on the review of the device history records, the image provided and complaint details atrium medical corporation cannot determine the actual presence of the foreign matter or determine if what was seen in the field came from the manufacturer or after the product was opened in the field. Atrium medical corporation 100% inspects every graft for particulate or foreign matter prior to packaging of the graft to ensure the product is clean.
Patient Sequence No: 1, Text Type: N, H10
[133363093]
N/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2018-01425 |
| MDR Report Key | 8127370 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-03 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2018-12-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVANTA SLIDER GDS |
| Generic Name | PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER |
| Product Code | DYF |
| Date Received | 2018-12-03 |
| Returned To Mfg | 2019-01-18 |
| Model Number | 22114 |
| Catalog Number | 22114 |
| Lot Number | 427108 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL |
| Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-03 |