D
Patient 1
IT WAS REPORTED THAT DURING A CORONARY BYPASS PROCEDURE THE VACUUM STABILIZER'S SUCTION STOPPED WORKING. ANOTHER DEVICE WAS RETRIEVED TO COMPLETE THE PROCEDURE AND NO PATIENT INJURY WAS REPORTED.
MAUDE MDR 1891211
- MDR report key
- 1891211
- Report number
- 2090040-2010-00014
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-09-24
- Date received
- 2010-11-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MS. MOIRA BARTON-VARTY
- Address
- 10232 S. 51ST STREET PHOENIX AZ 85044 US
- Phone
- 480-480-4807
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-11-04 | 0 |
Event Narratives#
N
Patient 1
THE COMPLAINT DEVICE WAS EVALUATED AND IT WAS FOUND THAT DRIED ADHESIVE WAS BLOCKING THE MAJORITY OF THE TUBING CONNECTION HOLE CONTRIBUTING TO THE INSUFFICIENT SUCTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED DEVICE INDICATED THAT THE STABILIZER PASSED ALL APPLICABLE TESTS AND INSPECTIONS PRIOR TO RELEASE. ASCENT HAS PROCEDURES IN PLACE TO PREVENT THE ADHESIVE FROM BLOCKING THE CONNECTION. THESE PROCEDURES ARE BEING REVIEWED TO ACCESS SUITABILITY. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.