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 2018-10-29 for DRAGONFLY DUO IMAGING CATHETER C408644 manufactured by St. Jude Medical.
[125280174]
An event of "patient's blood pressure dropped" and patient death was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information received, the cause of the reported incident could not be conclusively determined. The dragonfly duo imaging catheter instructions for use (ifu) states that coronary artery spasm may occur as a consequence of intravascular imaging. The dragonfly duo imaging catheter 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
[125280175]
Pre-dilatation with a non-abbott balloon was performed in lad. Next, the dragonfly duo imaging catheter revealed a thrombus in lad. Additional stenting was performed with two non-abbott stents and follow up ballooning for stent malposition. The dragonfly duo imaging catheter was then used to assess lad and left main (lm). During this time, the patient's blood pressure dropped and the oct procedure was stopped. Cpr was initiated, medications were administered and the patient's blood pressure was revived back. The patient's pressure remained unchanged after 40-45 minutes of cpr and intra-aortic balloon pump (iabp) insertion. The patient passed away. The physician does not believe the oct caused the adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00018 |
| MDR Report Key | 8013648 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2017-11-13 |
| Date Added to Maude | 2018-10-29 |
| 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 | STEPHANIE O' SULLIVAN |
| 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 DUO IMAGING CATHETER |
| Generic Name | INTRAVASCULAR IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2018-10-29 |
| Model Number | C408644 |
| Catalog Number | C408644 |
| Lot Number | 6193976 |
| Device Expiration Date | 2019-11-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 3. Life Threatening; 4. Other; 5. Required No Informationntervention | 2018-10-29 |