FDA Adverse Event
Injury
Summary report: N
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER.
MDR report key: 1890127
·
Received October 29, 2010
Report
- Report Number
- 1820334-2010-00534
- Event Type
- Injury
- Date Received
- October 29, 2010
- Date of Event
- September 29, 2010
- Report Date
- September 29, 2010
- Manufacturer
- COOK, INC.
- Product Code
- DQY
- PMA / PMN Number
- K091527
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT IS CURRENTLY UNDER INVESTIGATION.
Description of Event or Problem · 1
THE PHYSICIAN WAS PERFORMING A PTA ON THE HEPATIC AND PORTAL VEIN WHEN THE BALLOON RUPTURED CIRCUMFERENTIALLY. TE ATTEMPT TO TRY AND REMOVE THE BALLOON CATHETER THROUGH THE SHEATH CAUSED THE END TO BREAK FREE AND LODGE IN THE PATIENT'S PORTAL VEIN. THE PHYSICIAN HAD TO USE FORCEPS TO REMOVE THE DISTAL END OF THE BALLOON AND CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. | DQY CATHETER, PERCUTANEOUS | DQY | COOK, INC. | NA | 2484516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |