MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for 23MM X 4CM X 130CM EDWARDS BALLOON CATHETER 9350BC23 9350BC23A manufactured by Edwards Lifesciences Llc.
[94374488]
Patient Sequence No: 1, Text Type: N, H10
[94374489]
During deployment of the edwards tavr valve the inflation balloon ruptured and the valve was unable to be deployed
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7103926 |
| MDR Report Key | 7103926 |
| Date Received | 2017-12-11 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-10-19 |
| Report Date | 2017-10-31 |
| Date Reported to FDA | 2017-10-31 |
| Date Reported to Mfgr | 2017-10-31 |
| Date Added to Maude | 2017-12-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 23MM X 4CM X 130CM EDWARDS BALLOON CATHETER |
| Generic Name | BALLOON AORTIC VALVULOPLASTY |
| Product Code | OZT |
| Date Received | 2017-12-11 |
| Model Number | 9350BC23 |
| Catalog Number | 9350BC23A |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-11 |