FDA Adverse Event
Malfunction
Summary report: N
IAB: 8 FR - 30 CC FOS
MDR report key: 1915495
·
Received November 5, 2010
Report
- Report Number
- 1219856-2010-00797
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 13, 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
- JA
- Reporter Occupation
- UNKNOWN
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 IN THE CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE PHYSICIAN WAS INSERTING AN IAB VIA SUPER ARROW-FLEX (SAF) SHEATH WHEN HE ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER FORWARD. THE IAB CATHETER AND SHEATH WERE REMOVED TOGETHER. A DIFFERENT KIT WAS OBTAINED. THERE WERE NO PT DEATH, INJURIES OR COMPLICATIONS REPORTED. THE DELAY OF THERAPY IS UNK, WITH THE PT'S OUTCOME LISTED AS GOOD. REFERENCE MDR #1219856-2010-00796 FOR THE SECOND EVENT INVOLVING THE SAME PT. ADDITIONAL INFO RECEIVED FROM (B)(4) STATED THAT "THE LEFT FEMORAL ARTERY WAS USED IN BOTH EVENTS AND THE SAME INSERTION SITE WAS USED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 8 FR - 30 CC FOS | INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) | DSP | ARROW INTL., INC. | MF9099231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |