MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,06,07 report with the FDA on 2013-11-14 for DRAGONFLY 13751-05 manufactured by St Jude Medical (catd Westford).
[4147245]
The ilumien system displayed an error message indicating the dragonfly catheter and doc were not connecting properly so this dragonfly catheter was selected. During the procedure, the pt became hypotensive and experienced ventricular fibrillation when contrast was injected into the right coronary artery. Defibrillation was performed twice and the pt was stabilized. The pt was admitted to cardiology service, monitored overnight and remained stable. The physician was uncertain if the contrast injection triggered the ventricular fibrillation and had no concerns about the device performance.
Patient Sequence No: 1, Text Type: D, B5
[11361628]
St jude medical could not evaluate the dragonfly catheter involved in this incident since it was not returned to us. The dragonfly catheter's records could not be reviewed since the lot number for the affected product was not provided to st jude medical. The cause for the reported event remains unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009600098-2013-00001 |
| MDR Report Key | 3491256 |
| Report Source | 02,05,06,07 |
| Date Received | 2013-11-14 |
| Date of Report | 2013-10-05 |
| Date of Event | 2012-12-21 |
| Date Mfgr Received | 2013-10-05 |
| Date Added to Maude | 2013-11-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517562000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY |
| Product Code | ORD |
| Date Received | 2013-11-14 |
| Model Number | 13751-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST JUDE MEDICAL (CATD WESTFORD) |
| Manufacturer Address | WESTFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-11-14 |