MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-07-24 for DRAGONFLY DUO KIT C408643 manufactured by St. Jude Medical Catd.
[4773920]
A guidewire and a 2. 5mm sapphire balloon were advanced through a right coronary artery chronic total occlusion (cto). Ballooning was performed distal to the occlusion which resulted in a dissection. A dragonfly duo catheter was used to locate the true lumen of the vessel, however this attempt was unsuccessful because the vessel was completely occluded. An echo was performed and confirmed that the patient was okay. The dissection resolved itself. It was thought that the use of the dragonfly duo catheter may have made the dissection worse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2014-00003 |
| MDR Report Key | 4004671 |
| Report Source | 01,05,07 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-03 |
| Date of Event | 2014-07-03 |
| Date Mfgr Received | 2014-07-03 |
| Date Added to Maude | 2014-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE JOHNSON, RN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY DUO KIT |
| Generic Name | OCT IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2014-07-24 |
| Model Number | C408643 |
| Catalog Number | C408643 |
| Lot Number | 4486480 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL CATD |
| Manufacturer Address | WESTFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-24 |