MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for DRAGONFLY JP IMAGING CATHETER C408648 manufactured by St. Jude Medical.
[27917281]
(b)(4). Product evaluation: the device was not returned for evaluation and the catheter batch number was not provided to perform a device history record review. No case oct pullback or angiography data was provided for review. Communication was received that no additional information will be made available. Based on the information provided the investigation was limited and the investigation results are inconclusive. The cause for the reported event remains unknown. The dragonfly jp imaging catheter device instruction for use (ifu) warns and cautions the user to use the minimum flush rate and volume required to image the desired anatomy. The dragonfly jp imaging catheter device instruction for use (ifu) warns and cautions the user to refer to the contrast media instructions for use and general warnings and precautions relating to contrast media. The dragonfly jp imaging catheter device instruction for use (ifu) states that large thrombus is a contraindication for use of a dragonfly jp imaging catheter where introduction of any catheter would constitute a threat to patient safety. The dragonfly jp imaging catheter device instruction for use (ifu) states that abnormal heart arrhythmias are a complication that may occur as a consequence of intravascular imaging.
Patient Sequence No: 1, Text Type: N, H10
[27917282]
The following was published in the article, "periprocedural myocardial injury and right bundle branch block during coronary optical coherence tomography in an acute coronary syndrome patient with severe coronary ectasia," which was published to international journal of cardiology 177 (2014) 1113-1115 and available online on (b)(6) 2014: a patient with unstable angina and chest pain underwent emergent coronary angiography (cag) which showed a filling defect at the left anterior descending artery (lad) with flow limitation. A dragonfly catheter was used during oct to evaluate the filling defect and demonstrated a thrombus protruding into the dilated vessel. Continuous injections of iso-osmolar contrast flash at 3. 5ml/s were required four times to clear the oct image due to coronary ectasia. After the procedure, the patient complained of chest discomfort. An electrocardiogram test revealed complete right bundle-branch block, requiring isosorbide dinitrate and nicorandil. A cag confirmed that there were no structural changes in the lad artery or distal embolism. The author alleged that contrast flushing required for the oct acquisition may have contributed to myocardial injury. Http://dx. Doi. Org/10. 1016/j. Ijcard. 2014. 08. 082.
Patient Sequence No: 1, Text Type: D, B5
[28083750]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009600098-2015-00003 |
| MDR Report Key | 5138894 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-15 |
| Date Mfgr Received | 2015-09-15 |
| Date Added to Maude | 2015-10-08 |
| 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 JP IMAGING CATHETER |
| Generic Name | INTRAVASCULAR IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2015-10-08 |
| Model Number | C408648 |
| Catalog Number | C408648 |
| 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 | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-10-08 |