FDA Adverse Event
Death
Summary report: N
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
MDR report key: 1222585
·
Received November 6, 2008
Report
- Report Number
- 2522007-2008-00009
- Event Type
- Death
- Date Received
- November 6, 2008
- Date of Event
- October 9, 2008
- Report Date
- November 6, 2008
- Manufacturer
- COOK VASCULAR INC.
- Product Code
- DRE
- PMA / PMN Number
- K010055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT BEEN RETURNED FOR EVAL. NONE.
Description of Event or Problem · 1
COMPLAINT REPORT STATES, "SVC REPTURE WITH 9 FR EVOLUTION (&FR WAS USED 1ST), TRYING TO REMOVE 3/5, 4 Y/O LEADS SCARRED TOGETHER." SWITCHED MULTIPLE TIMES. DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET | VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION | DRE | COOK VASCULAR INC. | LR-EVN-9.0 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death |