FDA Adverse Event
Malfunction
Summary report: N
ENVOY 6F GUIDING CATHETERS
MDR report key: 1001655
·
Received February 14, 2008
Report
- Report Number
- 9616099-2008-00344
- Event Type
- Malfunction
- Date Received
- February 14, 2008
- Date of Event
- January 23, 2008
- Report Date
- January 24, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DQY
- PMA / PMN Number
- K021593
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS AVAILABLE FOR EVAL AND TESTING. HOWEVER, THE EVAL HAS NOT BEEN COMPLETED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
DURING PREP PRIOR TO UTILIZING IN THE PT, A LENGTH WISE TEAR ON THE HUB OF THE ENVOY CATHETER AND LEAKAGE WAS NOTED. THE PRODUCT WAS NOT CLINICALLY USED AND THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THERE WAS NO PT INJURY REPORTED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENVOY 6F GUIDING CATHETERS | CES GUIDING CATHETERS (DQY) | DQY | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |