FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 181065
·
Received August 5, 1998
Report
- Report Number
- 1220923-1998-00071
- Event Type
- Injury
- Date Received
- August 5, 1998
- Date of Event
- June 1, 1998
- Report Date
- July 7, 1998
- Manufacturer
- STRATO/INFUSAID, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 07/07/1998, THE FACILITY'S OR SUPERVISOR INFORMED THE MFR'S REP OF THE FOLLOWING: THE DEVICE WAS IMPLANTED ON 02/02/1998. A COUPLE WEEKS AGO (LAST WEEK OF JUNE 1998, EXACT DATE WAS NOT KNOWN), THE DEVICE CATHETER WAS NOTED TO HAVE SHEARED. THE SHEARED SEGMENT OF CATHETER WAS REMOVED AT A FACILITY AND WAS PLACED IN THE PT'S POSSESSION. THE DEVICE BODY WAS EXPLANTED TODAY (07/07/1998) AT THIS FACILITY. THE DEVICE AND SHEARED SEGMENT OF CATHETER WERE SCHEDULED TO BE RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM Implant | VASCULAR ACCESS DEVICE | LJT | STRATO/INFUSAID, INC. | NA | 13879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |