MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-24 for DRAGONFLY DUO KIT C408643 manufactured by St. Jude Medical.
[4373975]
The dragonfly duo catheter was used in a severely calcified right coronary artery (rca). Catheter advancement past the lesion was difficult but the location was reached and pullback was performed. During catheter removal, the distal 1-2 cm tip of the catheter detached in the rca ostium. Retrieval attempts with a snare resulted in tip embolization to the left internal iliac artery. Radial access was obtained and rca intervention continued; further snaring attempts were unsuccessful. The patient received dopamine 12 hours post procedure for hypotension. The patient is scheduled for a staged left anterior descending artery (lad) intervention and removal/treatment of the embolized tip when their condition is stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2014-00002 |
| MDR Report Key | 3784247 |
| Report Source | 05,07 |
| Date Received | 2014-04-24 |
| Date of Report | 2014-04-02 |
| Date of Event | 2014-04-02 |
| Date Mfgr Received | 2014-04-02 |
| Date Added to Maude | 2014-05-02 |
| 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, RN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY DUO KIT |
| Product Code | ORD |
| Date Received | 2014-04-24 |
| Model Number | C408643 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-04-24 |