MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-17 for DRANGONFLY * C408643 manufactured by Lightlab Imaging, Inc..
[4009793]
The dragonfly catheter did not work, it showed error message on the console. Taken off the field another one opened without problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3496400 |
| MDR Report Key | 3496400 |
| Date Received | 2013-10-17 |
| Date of Report | 2013-10-17 |
| Date of Event | 2013-10-11 |
| Report Date | 2013-10-17 |
| Date Reported to FDA | 2013-10-17 |
| Date Reported to Mfgr | 2013-12-03 |
| Date Added to Maude | 2013-12-03 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRANGONFLY |
| Generic Name | CATHETER, IMAGING, INTRAVASCULAR |
| Product Code | NQQ |
| Date Received | 2013-10-17 |
| Model Number | * |
| Catalog Number | C408643 |
| Lot Number | 4010692 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIGHTLAB IMAGING, INC. |
| Manufacturer Address | 4 ROBBINS RD WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-17 |