FDA Adverse Event
Death
Summary report: N
LINEAR 7.5 FR. 34CC IAB
MDR report key: 3946219
·
Received July 2, 2014
Report
- Report Number
- 2248146-2014-00172
- Event Type
- Death
- Date Received
- July 2, 2014
- Date of Event
- July 9, 2013
- Report Date
- August 28, 2013
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
CARDIAC ARREST OCCURRED DURING OPERATION. WHILE DOING CPR TO PT, TRIED TO USE IABP FOR PT. THE INSERTION WAS FAILED BECAUSE OF AORTA TORTUOUS. NO BLOOD WAS SEEN IN THE CATHETER TUBING. NO PT INJURY OR DEATH RESULTING FROM THE ABOVE EVENT. PT EXPIRED ON (B)(6) 2013 AT 17:04. PUMP: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385333 | LINEAR 7.5 FR. 34CC IAB | INTRA-AORTIC BALLOON | DSP | DATASCOPE CORP | 0684-00-0474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Death |