FDA Adverse Event
Injury
Summary report: N
ULTRAFLOW HCP 1.5F
MDR report key: 1051726
·
Received May 22, 2008
Report
- Report Number
- 2029214-2008-00093
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- April 22, 2008
- Report Date
- April 24, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PROXIMAL SECTION OF THE CATHETER WAS RETURNED FOR EVAL WITH APPROX 17.7 CM OF THE DISTAL SEGMENT MISSING. THE SEPARATION SITE HAS THE APPEARANCE OF EXPANDED CIRCUMFERENTIAL DILATATION CONSISTENT WITH BURSTS THAT MAY OCCUR DURING ANGIOGRAPHIC INJECTIONS. CATHETER SEPARATION.
Description of Event or Problem · 1
IT WAS REPORTED DURING CONTRAST INJECTION, THE CATHETER RUPTURED AT THE DISTAL SECTION WITH PART OF THE CATHETER WAS LEFT IN THE PT. UPON REMOVING THE BROKEN SEGMENT WITH A SNARE, THE VESSEL RUPTURED. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAFLOW HCP 1.5F | FLOW DIRECTED MICRO CATHETER | KRA | EV3 NEUROVASCULAR | 105-5066 | 5030825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |