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 2019-07-17 for ILUMIEN IMAGING SYSTEM 900-700-00 manufactured by St. Jude Medical Catd.
[151279322]
During the procedure, the imaging system screen went blank and upon removal of the catheter a thrombus was noted. The catheter was in the right coronary artery and after two runs, the screen went blank prior to the contrast being injected. The catheter was removed and thrombus was noted. The procedure was completed with angiography with no patient consequences. After the procedure, the system was tested and it was noticed that it was hard to start the system and the screens were blank. The oct runs were not all captured on the system. Alarms and beeping was heard coming from the system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2019-00016 |
| MDR Report Key | 8797799 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-17 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-07-02 |
| Date Mfgr Received | 2019-10-04 |
| Date Added to Maude | 2019-07-17 |
| 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 | ILUMIEN IMAGING SYSTEM |
| Generic Name | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) |
| Product Code | NQQ |
| Date Received | 2019-07-17 |
| Model Number | 900-700-00 |
| Catalog Number | 900-700-00 |
| Lot Number | 3488234 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2019-07-17 |