FDA Adverse Event
Death
Summary report: N
ELECTROSURGICAL DISSECTION SHEATH
MDR report key: 496995
·
Received November 19, 2003
Report
- Report Number
- 2522007-2003-00003
- Event Type
- Death
- Date Received
- November 19, 2003
- Date of Event
- March 18, 2002
- Report Date
- October 24, 2003
- Manufacturer
- COOK VASCULAR INC.
- Product Code
- MFA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING AN EXTRACTION PROCEDURE TO REMOVE TWO HEART LEADS PLACED 18 YEARS AGO, THE PT'S BLOOD PRESSURE BEGAN DROPPING AND A THORACOTOMY WAS PERFORMED. A LARGE VOLUME OF BLOOD WAS LOST. OVER AN HOUR WAS SPENT TRYING TO RESUSCITATE THE PT AND UNFORTUNATELY THEY WERE UNABLE TO GET THE PT STABILIZED WITH A BLOOD PRESSURE OR WITH A DEFINITIVE HEARTBEAT. THE PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTROSURGICAL DISSECTION SHEATH | INTRAVASCULAR RETRIEVAL DEVICE | MFA | COOK VASCULAR INC. | LR-EDS-9.0 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Death |