MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-24 for DRAGONFLY DUO C408644 manufactured by St. Jude Medical.
[21242280]
Catheter tip of st. Jude dragonfly catheter broke off during procedure. Diagnosis or reason for use: used during cardiac catheterization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035805 |
| MDR Report Key | 3777507 |
| Date Received | 2014-04-24 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-04-02 |
| Date Added to Maude | 2014-04-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY DUO |
| Generic Name | NONE |
| Product Code | ORD |
| Date Received | 2014-04-24 |
| Model Number | C408644 |
| Lot Number | 431911 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-24 |