FDA Adverse Event
Death
Summary report: N
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
MDR report key: 4212665
·
Received October 24, 2014
Report
- Report Number
- 2522007-2014-00014
- Event Type
- Death
- Date Received
- October 24, 2014
- Date of Event
- October 6, 2014
- Report Date
- October 24, 2014
- Manufacturer
- COOK VASCULAR INC.
- Product Code
- DRE
- PMA / PMN Number
- K061000
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
THE DISTRICT MANAGER WAS IN THE PROCEDURE AND INDICATED THE PT HAD A WEAK HEART. ONE LEAD WAS REMOVED AND THE LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH WAS OUT OF THE PT WHEN THE PT STARTED LOSING BLOOD AT THE POINT OF WHERE THE DEVICES WERE INSERTED. CPR WAS INITIATED AND EXTRA BLOOD WITH SALINE WAS TRANSFUSED IN THE PT. THE PT'S BLOOD PRESSURE NEVER CAME BACK AND THE PT EXPIRED. PT OUTCOME: PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679962 | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET | NONE | DRE | COOK VASCULAR INC. | N117039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death |