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 2019-06-28 for FRU M5 ENGINE R RFB 100122796 manufactured by St. Jude Medical Catd.
[149549453]
A pullback was performed and the images were dark and not sharp on the system. The procedure was not completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2019-00014 |
| MDR Report Key | 8745496 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-28 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-05-20 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2014-09-18 |
| Date Added to Maude | 2019-06-28 |
| 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 | FRU M5 ENGINE R RFB |
| Generic Name | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) |
| Product Code | NQQ |
| Date Received | 2019-06-28 |
| Model Number | 100122796 |
| Lot Number | 4793417 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2019-06-28 |