FDA Adverse Event
Malfunction
Summary report: N
OUTBACK RE-ENTRY CATHETER
MDR report key: 1062976
·
Received June 18, 2008
Report
- Report Number
- 9616099-2008-01543
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- May 26, 2006
- Report Date
- May 28, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DQY
- PMA / PMN Number
- K043534
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
DURING THE PROCEDURE TO TREAT A COMPLETE TOTAL OCCLUSION, THE OUTBACK LTD WAS PREP ACCORDING TO (IFU) INSTRUCTION FOR USE GUIDELINES, HOWEVER UPON INSPECTION, PRIOR TO INSERTING IN THE PATIENT, THE PHYSICIAN NOTICED THAT THE CANNULA WAS STICKING OUT. THE PRODUCT WAS NOT UTILIZED FOR THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OUTBACK RE-ENTRY CATHETER | CTO CATHETER SYSTEMS (DQY) | DQY | CORDIS DE MEXICO | NA | 13325439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |