FDA Adverse Event
Other
Summary report: N
SPYGLASS ANGIOGRAPHIC CATHETER 6F, MPA2
MDR report key: 561353
·
Received December 23, 2004
Report
- Report Number
- 2182269-2004-00232
- Event Type
- Other
- Date Received
- December 23, 2004
- Report Date
- December 23, 2004
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED DURING A RIGHT HEART CATH PROCEDURE, THE TIP OF THE CATHETER DETACHED AND MIGRATED TO THE PULMONARY VALVE THE PHYSICIAN WAS NOT TRACKING THE CATHETER OVER A GUIDEWIRE. A GUIDEWIRE WAS INSERTED TO RETREIVE THE CATHETER TIP. THE TIP WAS RETREIVED AND THERE WAS NO CONSEQUENCE TO THE PT. THE HOSP WAS ALSO COMPLAINING OF KINKING ISSUES WITH THE SYPGLASS PRODUCT LINE. IMAGES OF THE CASE WILL BE SENT FOR REVIEW. IT SHOULD BE NOTED THE REMAINING SPYGLASS PRODUCT LINE WAS THROWN OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPYGLASS ANGIOGRAPHIC CATHETER 6F, MPA2 | SYPGLASS 6F, MPA2 | DQO | ST. JUDE MEDICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Other |