MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-16 for DRAGONFLY * manufactured by Light Lab Imaging, Div St. Jude Medical.
[2723782]
Oct (optical coherence tomography) system would not recognize the catheter. Catheter was connected to its automatic withdrawal device and the "click" insured that there was a good connection. The system would not recognize the catheter and it kept prompting to connect and repeat the auto calibrate step. Tried a different catheter and it worked fine. Not documented if it was the same lot # as the defective device. Patient outcome was good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2581073 |
| MDR Report Key | 2581073 |
| Date Received | 2012-05-16 |
| Date of Report | 2012-05-16 |
| Date of Event | 2012-05-10 |
| Report Date | 2012-05-16 |
| Date Reported to FDA | 2012-05-16 |
| Date Added to Maude | 2012-05-21 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY |
| Generic Name | CATHETER, IMAGING, OPTICAL COHERENCE TOMOGRAPHY |
| Product Code | NQQ |
| Date Received | 2012-05-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | DF-11-857 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIGHT LAB IMAGING, DIV ST. JUDE MEDICAL |
| Manufacturer Address | 4 ROBBINS RD WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-16 |