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 2019-08-01 for DRAGONFLY DUO IMAGING CATHETER C408644 manufactured by St. Jude Medical Catd.
| Report Number | 3009600098-2019-00018 |
| MDR Report Key | 8850683 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-01 |
| Date of Report | 2019-08-16 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-08-14 |
| Device Manufacturer Date | 2017-06-13 |
| Date Added to Maude | 2019-08-01 |
| 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 CATD |
| 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 | OPTICAL COHERENCE TOMOGRAPHY, INTRAVASCULAR CATHETER |
| Product Code | ORD |
| Date Received | 2019-08-01 |
| Returned To Mfg | 2019-06-27 |
| Model Number | C408644 |
| Lot Number | 6015539 |
| Device Expiration Date | 2019-06-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-08-01 |