FDA Adverse Event
Malfunction
Summary report: N
IAB : 8 FR - 40 CC FOS
MDR report key: 1031468
·
Received April 18, 2008
Report
- Report Number
- 1219856-2008-00201
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- April 8, 2008
- Report Date
- April 18, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K021462
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED SHEATHLESS THROUGH THE LEFT FEMORAL ARTERY. BEFORE CONNECTING THE IAB TO THE AUTOCAT 2 WAVE CONSOLE BLOOD WAS FOUND IN THE DRIVELINE TUBING. THE IAB WAS PROMPTLY REMOVED FROM THE PT AND ANOTHER SUCCESSFULLY INSERTED. THE PHYSICIAN STATES THAT THE MOST LIKELY THE IAB WAS DAMAGED DURING THE INSERTION PROCEDURE, BUT HE IS UNABLE TO EXPLAIN THE CAUSE (PLAQUE, KINK, CENTRAL LUMEN FRACTURE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB : 8 FR - 40 CC FOS | INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) | DSP | ARROW INTL., INC. | MF8018848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | AUTOCAT 2 WAVE BALLOON PUMP |