N
Patient 1
ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.
MAUDE MDR 8127370
- MDR report key
- 8127370
- Report number
- 3011175548-2018-01425
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-26
- Date received
- 2018-12-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 40 CONTINENTAL BLVD MERRIMACK NH 03054 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ADVANTA SLIDER GDS | PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER | ATRIUM MEDICAL | DYF | 22114 | 22114 | 427108 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-03 | 0 | 1. R |
Event Narratives#
D
Patient 1
DURING THE IMPLANT OF AN ARTERIO-VENOUS GRAFT, THE CLINICIAN NOTICED SOME FOREIGN SUBSTANCE ON THE GRAFT.
N
Patient 1
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.
D
Patient 1
N/A.