FDA Adverse Event
Death
Summary report: N
BOSTON SCIENTIFIC
MDR report key: 705207
·
Received April 25, 2006
Report
- Report Number
- 1317056-2006-00023
- Event Type
- Death
- Date Received
- April 25, 2006
- Date of Event
- January 13, 2006
- Report Date
- March 25, 2006
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- BYX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RECEIVED, VIA COPY OF END USER MEDWATCH #2201630000-2006-8005 NOTIFICATION OF A PATIENT DEATH: "PATIENT UNDERWENT STENTING PROCEDURE, WENT INTO VFIB ARREST PRIOR TO END OF PROCEDURE AND EXPIRED." PER COVER LETTER RECEIVED FROM HOSPITAL, THE POSSIBILITY OF AIR BEING INTRODUCED DURING THE PROCEDURE POSSIBILITY CONTRIBUTED TO THE PATIENT'S DEATH. THE HOSPITAL IS RETAINING THE USED DEVICES. GUIDANT CORPORATION (CO-PILOT) BLEEDBACK CONTROL VALVE, REF #1003331, LOT 511951) AND MERIT MEDICAL (MANIFOLD KIT #K09-00970P) WERE ALSO NOTIFIED BY THE HOSPITAL OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOSTON SCIENTIFIC | PRESSURE MONITORING LINE | BYX | BOSTON SCIENTIFIC | NA | 1079486 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Death |