MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-01-26 for DRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER C408646 manufactured by St. Jude Medical.
[98402596]
The reported event 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 device history record could not be reviewed because the batch number was unavailable. The dragonfly optis instructions for use (ifu) states that coronary artery spasm may occur as a consequence of intravascular imaging. The dragonfly optis instructions for use (ifu) states that abnormal heart arrhythmias may occur as a consequence of intravascular imaging.
Patient Sequence No: 1, Text Type: N, H10
[98402597]
The patient received a normal coronary angio and the left main coronary artery (lm) and left anterior descending coronary artery (lad) stenting was performed in vessels of small diameter. Oct was completed successfully and the stent was well apposed. After oct, the patient had a hemodynamic crash, the bp dropped, and the ecg showed ischemic changes. The patient had ventricular tachycardia (vt) two times and was successfully treated by defibrillation to a normal rhythm. The patient experienced pulseless electrical activity (pea) and cpr was administered. The circumflex coronary (cx) artery was stented successfully, but the patient's condition remained unresolved. The lad was re-stented, but a pre-dilatation device could not be delivered to the lad. Then a counter pulsator device was used to assist coronary flow, but there was no hemodynamic benefit. There was no flow in the left coronary. After an hour and a half of cpr, the patient expired. The batch number for the dragonfly optis catheter was not recorded by the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00003 |
| MDR Report Key | 7222519 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-26 |
| Date of Report | 2018-01-26 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2018-01-26 |
| 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 | 2018-01-26 |
| 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; 2. Required No Informationntervention | 2018-01-26 |