MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-24 for DRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER C408646 manufactured by St. Jude Medical.
[98160403]
An event of "dissection in the left main" was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. The device history report could not be reviewed because the batch number was unavailable. The dragonfly optis instructions for use states arterial dissection or death may occur as a consequence of intravascular imaging.
Patient Sequence No: 1, Text Type: N, H10
[98160404]
During oct pullback, a dissection was observed in the left main, which was reported to be caused by the dragonfly optis catheter. The dissection was treated with stenting in the left main and placement of a non-abbott support device. Cpr was performed, but the patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00004 |
| MDR Report Key | 7217077 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-24 |
| Date of Report | 2018-01-24 |
| Date of Event | 2017-12-30 |
| Date Mfgr Received | 2018-01-03 |
| Date Added to Maude | 2018-01-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 4 ROBBINS DRIVE |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01886 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER |
| Generic Name | DRAGONFLY? OPTIS |
| Product Code | ORD |
| Date Received | 2018-01-24 |
| Model Number | C408646 |
| Catalog Number | C408646 |
| 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 | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-01-24 |