MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-10 for TVC INSIGHT CATHETER TVC-C195-20 manufactured by Infraredx, Inc..
[91796516]
Percutaneous coronary intervention of the left anterior descending (lad) coronary artery. Diagnostic imaging with a combination near-infrared spectroscopy (nirs) and intravascular ultrasound (ivus) catheter. Thrombus was formed in the lad while attempting to cross a lesion with the nirs-ivus catheter. The catheter was removed and the thrombus was aspirated with an aspiration catheter to restore blood flow. No further attempt was made to use the nirs-ivus catheter following aspiration. Operator reported feeling resistance while attempting to cross the lesion through the tortuous vessel, possibly harming the intima and causing a thrombus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004722468-2017-00003 |
| MDR Report Key | 7023059 |
| Date Received | 2017-11-10 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-10-06 |
| Date Facility Aware | 2017-10-17 |
| Report Date | 2017-10-17 |
| Date Reported to Mfgr | 2017-10-17 |
| Date Mfgr Received | 2017-10-17 |
| Device Manufacturer Date | 2017-02-21 |
| Date Added to Maude | 2017-11-10 |
| 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 | 34 THIRD AVE |
| Manufacturer City | BURLINGTON MA 018034414 |
| Manufacturer Country | US |
| Manufacturer Postal | 018034414 |
| Manufacturer Phone | 7813459651 |
| Manufacturer G1 | INFRAREDX, INC. |
| Manufacturer Street | 34 THIRD AVE |
| Manufacturer City | BURLINGTON MA 018034414 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 018034414 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TVC INSIGHT CATHETER |
| Generic Name | ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER |
| Product Code | OGZ |
| Date Received | 2017-11-10 |
| Returned To Mfg | 2017-10-26 |
| Model Number | TVC-C195-20 |
| Lot Number | G37614 |
| Device Expiration Date | 2018-08-21 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INFRAREDX, INC. |
| Manufacturer Address | 34 THIRD AVE BURLINGTON MA 018034414 US 018034414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-11-10 |