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 2017-02-23 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical Catd.
[68167447]
(b)(4). The results of the investigation are inconclusive since the device was not returned for analysis. Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures. Based on the information received, the cause of the reported incident could not be conclusively determined. The dragonfly optis catheter instructions for use (ifu) state use the minimum flush rate and volume required to image the desired anatomy. Refer to contrast media instructions for use for general warnings and precautions relating to contrast media. The dragonfly optis catheter ifu state that abnormal heart arrhythmias and acute myocardial infarction are complications that may occur as a consequence of intravascular imaging.
Patient Sequence No: 1, Text Type: N, H10
[68167448]
After crossing a dragonfly optis catheter into the lesion an st elevation was noticed oct imaging was continued. A solution of 100% contrast was purged manually and a pullback was initiated. The patient experienced ventricular fibrillation and went into cardiac arrest. A dc defibrillator and cardiac massage were used and the patients vital signs and blood flow recovered. The pci procedure was continued and completed successfully. The physician did not believe the dragonfly optis catheter caused any adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2017-00001 |
| MDR Report Key | 6353850 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-09 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-02-09 |
| Device Manufacturer Date | 2016-11-08 |
| Date Added to Maude | 2017-02-23 |
| 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? CATHETER |
| Generic Name | DFII KITBOX OUS (NO SYRINGE) |
| Product Code | NQQ |
| Date Received | 2017-02-23 |
| Model Number | C408641 |
| Catalog Number | C408641 |
| Lot Number | 5702657 |
| Device Expiration Date | 2018-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL CATD |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-23 |