FDA Adverse Event
Malfunction
Summary report: N
IAB : 8 FR - 40 CC FOS
MDR report key: 1856678
·
Received September 10, 2010
Report
- Report Number
- 1219856-2010-00617
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- August 18, 2010
- Report Date
- September 9, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
REFERENCE MDR# 1219856-2010-00616 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PLACE A SECOND INTRA-AORTIC BALLOON VIA THE RIGHT FEMORAL ARTERY USING A SUPER ARROW-FLEX (SAF) SHEATH TO SUPPORT THE PT FOLLOWING OPEN HEART SURGERY AND TO ASSIST IN WEANING FROM THE BYPASS PUMP. THE IAB WOULD NOT ADVANCE THROUGH THE SHEATH AND THEY WERE REMOVED TOGETHER. THE PHYSICIAN SUCCESSFULLY PLACED THE THIRD IAB-05840-LWS USING A 9 FR. SHEATH, NOT FROM THE KITS. THE PT WAS WEANED OFF BYPASS PUMP AND TRANSFERRED TO INTENSIVE CARE UNIT WITH A SATISFACTORY OUTCOME FOLLOWING THE PROCEDURE.
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. | MF0063595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | INTRA-AORTIC BALLOON PUMP |