FDA Adverse Event
Death
Summary report: N
MAGNUM DISPOSABLE CORE BIOPSY INSTRUMENT
MDR report key: 4435793
·
Received January 15, 2015
Report
- Report Number
- 2020394-2015-00013
- Event Type
- Death
- Date Received
- January 15, 2015
- Date of Event
- November 25, 2014
- Report Date
- December 19, 2014
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- FCG
- PMA / PMN Number
- K934370
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE CONCLUSION OF A CT GUIDED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST. THE PATIENT EXPIRED DESPITE RESUSCITATIVE ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36919 | MAGNUM DISPOSABLE CORE BIOPSY INSTRUMENT | FCG | BARD PERIPHERAL VASCULAR, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |