FDA Adverse Event
Malfunction
Summary report: N
IAB : 8 FR - 40 CC FOS
MDR report key: 1915494
·
Received November 5, 2010
Report
- Report Number
- 1219856-2010-00798
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- June 30, 2010
- Report Date
- November 4, 2010
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K021462
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS BLOCKED DURING INSERTION THROUGH THE SUPER ARROW-FLEX (SAF) SHEATH. THE IAB AND SAF SHEATH WERE WITHDRAWN AND ANOTHER IAB-05840-U WAS SUCCESSFULLY USED. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS. THERE WAS NO DELAY IN THERAPY AND THE PT'S OUTCOME WAS LISTED AS FINE. IT WAS NOTED THAT AFTER RECEIVING THE FIELD SAFETY ALERT IN OCTOBER, THE CUSTOMER REPORTED THIS EVENT WHICH THEY ORIGINALLY THOUGHT WAS MISUSE.
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. | MF0011099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |