MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-01-16 for TVC INSIGHT CATHETER TVC-C195-22 manufactured by Infraredx Inc..
[5416784]
Percutaneous coronary intervention: successful deployment of 3. 5 x 18mm resolute des to mid-lcx, 75% to 0% with excellent angiographic result and timi 3 flow. Dissection was noted proximal to the mid-stent, successfully covered with stent in proximal lcx. Successful deployment of 3. 5 x 18mm resolute des to proximal lcx, 75% to 0% with excellent angiographic results and timi 3 flow. Patient underwent a complex intervention and had chest pain during the procedure. No complications were noted during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[12923218]
Catheter was returned and was inspected both visually and functionally. There were no visual evidence of failure or mis-use. The catheter had no visual signs of kinking or breakage. Catheter was shown to be fully functionally, tacking well through a simulated arch and producing both an ivus image as well as nir data. No problem found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004722468-2014-00003 |
| MDR Report Key | 4431960 |
| Report Source | 99 |
| Date Received | 2015-01-16 |
| Date of Report | 2015-01-15 |
| Date of Event | 2014-12-16 |
| Date Mfgr Received | 2014-12-17 |
| Date Added to Maude | 2015-01-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE CHARTIER |
| Manufacturer Street | 34 THIRD AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7813459593 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TVC INSIGHT CATHETER |
| Generic Name | NIRS IVUS CORONARY IMAGING CATHETER |
| Product Code | OGZ |
| Date Received | 2015-01-16 |
| Returned To Mfg | 2014-12-23 |
| Model Number | TVC-C195-22 |
| Lot Number | D01234 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INFRAREDX INC. |
| Manufacturer Address | 34 THIRD AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-01-16 |