FDA Adverse Event
Malfunction
Summary report: N
IAB: 8 FR - 40 CC
MDR report key: 1934602
·
Received November 24, 2010
Report
- Report Number
- 1219856-2010-00857
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 22, 2010
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K000729
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MALE WAS IN THE CATH LAB. THE INTRA-AORTIC BALLOON (IAB) WAS BEING PLACED PRIOR TO BYPASS SURGERY IN THE LEFT FEMORAL ARTERY. THE PHYSICIAN INSERTED THE IAB IN THE SUPER ARROW-FLEX (SAF) SHEATH AND ENCOUNTERED DIFFICULTY ADVANCING. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS NOTED. THE DELAY IN TREATMENT WAS 15 MINUTES AND THE PT REQUIRED MEDICAL INTERVENTION WHILE REPLACING THE IAB. REF MDR# 1219856-2010-00858 FOR THE SECOND EVENT INVOLVING THE SAME PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 8 FR - 40 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | MF0063353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |