FDA Adverse Event
Other
Summary report: N
SUBMARINE PLUS PTA BALLOON CATHETER
MDR report key: 2923329
·
Received May 3, 2007
Report
- Report Number
- 2183870-2007-00032
- Event Type
- Other
- Date Received
- May 3, 2007
- Date of Event
- January 21, 2007
- Report Date
- April 4, 2007
- Manufacturer
- EV3 INC.
- Product Code
- MCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THIS PROCEDURE WAS PERFORMED IN THE INTERNAL CAROTID ARTERY: PATIENT WAS UNDERGOING AN ANGIOGRAPHY PROCEDURE AND HAD THE SUBMARINE BALLOON CATHETER IN THE INTERNAL CAROTID ARTERY WHERE IT RUPTURED. IT WAS REMOVED AND THE PROCEDURE CONTINUED, NO ADVERSE EFFECTS WERE NOTED AT THE TIME OF THE RUPTURE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED TRANSIENT ISCHEMIA ATTACK (TIA) LIKE SYMPTOMS THAT LASTED 2 HOURS AND RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBMARINE PLUS PTA BALLOON CATHETER | BALLOON | MCW | EV3 INC. | SUV030020090 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |