MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-12-20 for DRAGONFLY JP C408648 manufactured by St. Jude Medical.
[4213771]
The dragonfly jp catheter was inserted into the coronary artery. The physician flushed the catheter again with contrast using a syringe, as he felt it had not been flushed enough. The physician believed the flushing was not correct since there was too much fluid and no resistance felt. Then, the patient's hemodynamic status became unstable (slow flow). Medicine was given to stabilize the patient. The patient was discharged in stable condition after an additional 1 day stay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2013-00003 |
| MDR Report Key | 3553393 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-06 |
| Date of Event | 2013-12-05 |
| Date Mfgr Received | 2013-12-06 |
| Date Added to Maude | 2014-01-07 |
| 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 JP |
| Product Code | ORD |
| Date Received | 2013-12-20 |
| Model Number | C408648 |
| Lot Number | 4138413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | WESTFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-12-20 |