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 2017-10-27 for DRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER C408646 manufactured by St. Jude Medical.
[90473156]
The reported event of "the left anterior descending had occluded" could not be confirmed. 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 dragonfly optis instructions for use states total occlusion may occur as a consequence of intravascular imaging.
Patient Sequence No: 1, Text Type: N, H10
[90473157]
Following successful ffr of the left anterior descending artery using a pressurewire x, the decision was made to image the vessel using the dragonfly optis catheter. The dragonfly optis catheter was prepped and inserted over the pressurewire into the lad. Following insertion, an angiogram revealed the left anterior descending had occluded. The dragonfly optis catheter was removed and subsequent angioplasty and stent placement was performed. Coronary blood flow was restored and the patient was held as an inpatient for observation for a total of 2 days. At the time of discharge the patient was stable and had no residual effects from this event. Patient followed up with physician 1 week post cath and was found to be doing well with no complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2017-00006 |
| MDR Report Key | 6984835 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-10-04 |
| Date Mfgr Received | 2017-10-17 |
| Date Added to Maude | 2017-10-27 |
| 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 IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2017-10-27 |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-10-27 |