FDA Adverse Event
Malfunction
Summary report: N
VISTA BRITE TIP GUIDING CATHETERS
MDR report key: 1052029
·
Received May 20, 2008
Report
- Report Number
- 9616099-2008-01359
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- April 20, 2008
- Report Date
- April 25, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DQY
- PMA / PMN Number
- K021593
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORT RECEIVED FROM THE ACCOUNT INDICATED THAT THE GUIDING CATHETER BROKE APPROXIMATELY 3 INCHES FROM THE DISTAL END WHILE BEING REMOVED FROM ITS STERILE PACKAGING. THE BROKEN SEGMENT SEPARATED TOTALLY FROM THE REST OF THE GUIDE. THE PRODUCT WAS NEVER USED CLINICALLY. THE PRODUCT IS AVAILABLE FOR EVAL AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISTA BRITE TIP GUIDING CATHETERS | CARDIOLOGY GUIDING CATHETERS (DQY) | DQY | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |