FDA Adverse Event
Malfunction
Summary report: N
ARTEGRAFT COLLAGEN VASCULAR GRAFT
MDR report key: 3040983
·
Received January 25, 2007
Report
- Report Number
- 2247686-2006-00007
- Event Type
- Malfunction
- Date Received
- January 25, 2007
- Date of Event
- July 18, 2006
- Report Date
- January 22, 2007
- Manufacturer
- ARTEGRAFT, INC.
- Product Code
- LXA
- PMA / PMN Number
- N16837
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF RECENT COMPLAINT/MDR RECORDS DO NOT REFLECT SIGNIFICANT SIMILAR INCIDENTS OF VASCULAR GRAFT LEAKING INJURY OR INTERVENTIONS. ARTEGRAFT QUALITY MANAGEMENT DOES REVIEW COMPLAINT TRENDING FOR SIMILAR TYPES OF PROBLEMS AND ISSUES ON A PERIODIC BASIS. THIS WILL CONTINUE PER STANDARD PROCEDURE. CA AS REQUIRED.
Description of Event or Problem · 1
CUSTOMER, (B)(6) GENERAL HOSPITAL, COMPLAINED OF BLOOD LEAKING FROM ARTERIAL VASCULAR GRAFT AFTER IMPLANTATION IN THE RIGHT LEG. CUSTOMER STATED THE LEAKING WAS FROM A HOLE IN THE GRAFT ON (B)(6) 2006. THE VASCULAR GRAFT SERIAL NUMBER WAS EITHER (B)(4), DUE TO CONFUSION BY THE CUSTOMER DURING IMPLANTATION. THE VASCULAR GRAFT IN QUESTION WAS RETURNED IN HOSPITAL PACKAGING FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTEGRAFT COLLAGEN VASCULAR GRAFT | VASCULAR GRAFT | LXA | ARTEGRAFT, INC. | AG740 | 06D072-011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |