FDA Adverse Event
Death
Summary report: N
TRELLIS 8 120X30
MDR report key: 1905865
·
Received November 18, 2010
Report
- Report Number
- 2953724-2010-00138
- Event Type
- Death
- Date Received
- November 18, 2010
- Date of Event
- October 31, 2010
- Report Date
- November 1, 2010
- Manufacturer
- COVIDIEN
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER, CONTINUOUS FLOW. THE CUSTOMER REPORTS THAT DURING THE SECOND RUN IN THE RIGHT ILIAC VEIN, THE ODU WIRE APPEARED TO BE BROKEN. AT THIS POINT, THE DOCTOR TERMINATED THE PROCEDURE, ASPIRATED THE TREATMENT AREA AND REMOVED ALL PIECES OF THE TRELLIS. POST PROCEDURE, THE PT WAS GIVEN SEVERAL UNITS OF BLOOD, BUT EXPIRED ABOUT TWO HOURS POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRELLIS 8 120X30 | CATHETER, CONTINUOUS FLOW | KRA | COVIDIEN | BVT812030 | P1030017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |