FDA Adverse Event
Malfunction
Summary report: N
TRELLIS 8 120X30
MDR report key: 1503831
·
Received September 16, 2009
Report
- Report Number
- 2953724-2009-00012
- Event Type
- Malfunction
- Date Received
- September 16, 2009
- Date of Event
- August 21, 2009
- Report Date
- August 21, 2009
- Manufacturer
- COVIDIEN
- Product Code
- KRA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
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) 2009 THAT A CUSTOMER HAD AN ISSUE WITH A TRELLIS DEVICE. IT WAS REPORTED THE OSCILLATION DRIVE UNIT (ODU) STOPPED ROTATION AFTER 10 MINUTES OF THE FIRST RUN AND 7 MINUTES OF THE 2ND RUN. DISTAL BALLOON WOULD NOT DEFLATE AND HAD TO BE PUNCTURED AND EVACUATED BEFORE THE DEVICE COULD BE REMOVED. THE ODU WIRE HAD WRAPPED AROUND ITSELF INSIDE THE ASPIRATION LUMEN WITHIN THE CATHETER. THE WHOLE DEVICE WAS PULLED BACK TO LEVEL OF SKIN ENTRY POINT AND THE BALLOON DEFLATED. THIRD RUN DONE WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRELLIS 8 120X30 | CATHETER, CONTINUOUS FLOW | KRA | COVIDIEN | BVT812030 | P09-30097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |