MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-14 for DRAGONFLY DUO IMAGING CATHETER C408644 manufactured by St. Jude Medical Catd (westford, Ma).
[108227066]
The dragonfly duo imaging catheter failed to connect to the doc. The case was abandoned and rescheduled for a later date. Information received (b)(6) 2018, indicated the patient had been prepped and received local anesthesia before the case was abandoned. Patient specific information of patient identifier, age or birthdate, and weight are not available for this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00011 |
| MDR Report Key | 7512807 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-14 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2018-06-01 |
| Device Manufacturer Date | 2017-04-18 |
| Date Added to Maude | 2018-05-14 |
| 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 | 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 CATD (WESTFORD, MA) |
| 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 | 2018-05-14 |
| Returned To Mfg | 2018-04-24 |
| Model Number | C408644 |
| Catalog Number | C408644 |
| Lot Number | 5920389 |
| ID Number | 00183739000708 |
| Device Expiration Date | 2019-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL CATD (WESTFORD, MA) |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-14 |