MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-05 for C7 DRAGONFLY 100-100-00(13751-05) * manufactured by St. Jude Medical, Inc..
[2443887]
Catheter did not work, or calibrate. When plugged into the system it would not calibrate. It seemed to be a bad catherter; used another catheter from the same lot number and it worked fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2365954 |
| MDR Report Key | 2365954 |
| Date Received | 2011-12-05 |
| Date of Report | 2011-11-21 |
| Date of Event | 2011-11-11 |
| Report Date | 2011-11-21 |
| Date Reported to FDA | 2011-12-05 |
| Date Added to Maude | 2011-12-12 |
| 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 |
| 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 | C7 DRAGONFLY |
| Generic Name | CATHETER, IMAGING, INTRAVASCULAR, OCT |
| Product Code | NQQ |
| Date Received | 2011-12-05 |
| Model Number | 100-100-00(13751-05) |
| Catalog Number | * |
| Lot Number | DF 11-380 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 1 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-05 |