MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-12-19 for DUALPRO? IVUS+NIRS IMAGING CATHETER TVC-C195-42 manufactured by Infraredx, Inc..
| Report Number | 3004722468-2019-00005 |
| MDR Report Key | 9500019 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-12-19 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-11-28 |
| Date Facility Aware | 2019-12-17 |
| Report Date | 2019-12-17 |
| Date Reported to Mfgr | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2019-06-07 |
| Date Added to Maude | 2019-12-19 |
| 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 | MR. STEPHEN SUM |
| Manufacturer Street | 28 CROSBY DRIVE SUITE 100 |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7813459651 |
| Manufacturer G1 | INFRAREDX, INC. |
| Manufacturer Street | 28 CROSBY DRIVE SUITE 100 |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUALPRO? IVUS+NIRS IMAGING CATHETER |
| Generic Name | ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER |
| Product Code | OGZ |
| Date Received | 2019-12-19 |
| Model Number | TVC-C195-42 |
| Lot Number | 906033 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INFRAREDX, INC. |
| Manufacturer Address | 28 CROSBY DRIVE, SUITE 100 BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-19 |