N
Patient 1
(B)(6).
MAUDE MDR 9908511
- MDR report key
- 9908511
- Report number
- 2134265-2020-04203
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-19
- Date received
- 2020-03-31
- 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
- JAY JOHNSON
- Address
- TWO SCIMED PLACE MAPLE GROVE MN 55311 US
- Phone
- 763-763-7634
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MUSTANG | CATHETER, BILIARY, DIAGNOSTIC | BOSTON SCIENTIFIC CORPORATION | FGE | 24674 | 24674 | 0024943005 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.