FDA Adverse Event
Injury
Summary report: N
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
MDR report key: 3597227
·
Received January 14, 2014
Report
- Report Number
- 1820334-2014-00024
- Event Type
- Injury
- Date Received
- January 14, 2014
- Report Date
- December 17, 2013
- Manufacturer
- COOK, INC.
- Product Code
- DQY
- PMA / PMN Number
- K091527
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IT WAS REPORTED TO THE COOK REPRESENTATIVE THAT THE INCIDENT WAS REPORTED TO THE FDA BUT DATE NOT PROVIDED. EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE PHYSICIAN WAS DOING A VENA SYSTEM BALLOONING IN THE FFA, WHEN INFLATED THE BALLOON BURST. THE PHYSICIAN USED BRONCHIAL FORCEPS TO REMOVE THE BALLOON FRAGMENTS. NO HARM TO THE PATIENT. AT THIS POINT, THE PROCEDURE WAS COMPLETED SO NO FURTHER ACTIONS WERE NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36609 | ADVANCE 35 LP LOW PROFILE BALLOON CATHETER | DQY CATHETER, PERCUTANEOUS | DQY | COOK, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |