N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9859268
- MDR report key
- 9859268
- Report number
- 1220452-2020-00035
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-12
- Date received
- 2020-03-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- TONI O'DOHERTY
- Address
- PARKMORE BUSINESS PARK WEST GALWAY
- Phone
- 91-91-0917
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PWP CATHETER | CATHETER, INTRAVASCULAR, DIAGNOSTIC | MEDTRONIC, INC | DQO | 150075 | 150075 | 0009874487 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-20 | 0 |
Event Narratives#
D
Patient 1
THREE PULMONARY WEDGE PRESSURE CATHETER WERE ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A NON TORTUOUS, NON CALCIFIED VEINOUS SYSTEM IN THE RIGHT HEARTH CATH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE DEVICES WERE REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICES WERE INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO FLOAT THE PULMONARY WEDGE PRESSURE CATHETER WITH THE BALLOON INFLATED THROUGH A PREVIOUSLY IMPLANTED VENOUS STENT AND THE STENT STRUTS BURST THE BALLOON. THE PROCEDURE WAS COMPLETE BY PASSING ANOTHER PULMONARY WEDGE PRESSURE CATHETER UNINFLATED THROUGH THE STENT. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE CATHETERS THAT HAD THE RUPTURED BALLOONS. THE PATIENT IS ALIVE WITH NO INJURY.
N
Patient 1
IT WAS REPORTED THAT THE UNKNOWN BRAND VENOUS STENT LOOKED OK AFTER INTERACTION WITH THE PULMONARY WEDGE PRESSURE BALLOONS. THE USUAL MEDIUM, AND VOLUME OF MEDIUM (MLS) WAS USED AS WITH SEVERAL OTHER SUCCESSFUL PROCEDURES. THE PHYSICIAN ASSESSED THAT THE VENOUS STENT CAUSED THE RUPTURED BALLOONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.