MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-03-03 for DRAGONFLY DUO KIT C408643 manufactured by St. Jude Medical.
[4242205]
Vascular access was obtained via the right radial artery which perforated after the sheath and guidewire were inserted. A non-sjm guidewire was advanced into the distal left anterior descending (lad) artery and the dragonfly duo catheter was advanced into the mid lad. When contrast was injected into the mid lad, it did not flow beyond the tip of the catheter; therefore, pullback was not performed as the system did not sense the contrast injection. Immediately afterwards, the patient's intracoronary pressure dropped. The dragonfly duo catheter was removed from the patient. Angiography confirmed excessive clot formation in the mid and proximal lad. The patient went into cardiorespiratory arrest, multiple aspiration thrombectomies were performed but the patient expired. Information obtained indicated that the event was caused by patient factors.
Patient Sequence No: 1, Text Type: D, B5
[11665720]
The results of the investigation are inconclusive since the device was not returned for analysis. A review of the device history record was not possible since the lot number was unavailable. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009600098-2014-00001 |
| MDR Report Key | 3687719 |
| Report Source | 05,06,07 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-02-03 |
| Date of Event | 2014-01-27 |
| Date Mfgr Received | 2014-02-03 |
| Date Added to Maude | 2014-03-20 |
| 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 DUO KIT |
| Product Code | ORD |
| Date Received | 2014-03-03 |
| Model Number | C408643 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2014-03-03 |