N
Patient 1
THE LOT NUMBER OF THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION IS CURRENTLY UNDERWAY. (EXPIRY DATE: 06/2020).
MAUDE MDR 9199710
- MDR report key
- 9199710
- Report number
- 2020394-2019-04026
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-09-19
- Date received
- 2019-10-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JUDITH LUDWIG
- Address
- 1415 W. 3RD STREET TEMPE AZ 85281 US
- Phone
- 480-480-4803
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PRESTO INFLATION DEVICE | INFLATION DEVICE | BARD PERIPHERAL VASCULAR, INC. | MAV | ID4030 | ID4030 | PID1906076 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-10-16 | 0 | 1. D |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC VEIN, THE MONOMETER WAS ALLEGEDLY NOT WORKING. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE BUT NO DIAL TO DETERMINE THE ATMS. IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED FROM A PULMONARY EMBOLISM.