FDA Adverse Event
Other
Summary report: N
TUNA
MDR report key: 503421
·
Received December 29, 2003
Report
- Report Number
- 2950887-2003-01204
- Event Type
- Other
- Date Received
- December 29, 2003
- Date of Event
- December 1, 2003
- Report Date
- December 3, 2003
- Manufacturer
- MEDTRONIC GASTROENTEROLOGY/UROLOGY
- Product Code
- GEI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP REPORTED THAT DURING A TUNA PROCEDURE ONE NEEDLE APPEARED TO QUIT FUNCTIONING AFTER 2-3 LESIONS HAD BEEN CREATED. A SECOND CARTRIDGE WAS USED TO CONTINUE THE PROCEDURE WHICH DEVELOPED HIGH IMPEDANCE READINGS AND DIFFICULTY WITH THE NEEDLE SHEATH RETRACTING. THE PROCEDURE WAS COMPLETED USING A THIRD CARTRIDGE. FOLLOWING THE PROCEDURE IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING BLEEDING WITH CLOT RETENTION. THE PATIENT WAS HOSPITALIZED AND TREATED WITH CATHETERIZATION AND BLADDER IRRIGATIONS. BLOOD TRANSFUSIONS WERE NOT REQUIRED AND THE PATIENT WAS SCHEDULED FOR DISCHARGE ON THE THIRD DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUNA | EEA | GEI | MEDTRONIC GASTROENTEROLOGY/UROLOGY | 1900TU | 3G006V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization | EEA MODEL 1900TU LOT# 3G060V. |