MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-10 for TVC INSIGHT CATHETER NIRS-MC7-7-3.2F manufactured by Infraredx Inc..
[3908345]
Patient experienced ventricular fibrillation during catheter dwell time. Via right femoral artery with seldinger technique and one wall stick, the right femoral artery was entered and a 6 french sheath was placed. A number 4 left selective coronary catheter was advanced to the ascending aorta. The left coronary catheter selectively cannulated. Numerous injections performed with digital filming. This catheter replaced by number 4 right selective coronary catheter. It was advanced to the ascending aorta, the right coronary artery selectively cannulated. Numerous injections performed with just digital filming. Replaced with pigtail catheter. Pressures were recorded and all catheters were removed. Moved on to imaging as well as fractional flow wire. During imaging catheter may have occluded flow due to stenosis. Ventricular tachycardia fibrillation developed requiring cardioversion promptly back to baseline. Physician reported event was due to ischemia from long dwell time - would have occurred with any ivus catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004722468-2013-00002 |
| MDR Report Key | 3412997 |
| Report Source | 07 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-10-10 |
| Date of Event | 2013-03-21 |
| Date Mfgr Received | 2013-09-17 |
| Date Added to Maude | 2013-10-17 |
| 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 | 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 | NIR/IVUS CORONARY IMAGING CATHETER |
| Product Code | OGZ |
| Date Received | 2013-10-10 |
| Model Number | NIRS-MC7-7-3.2F |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INFRAREDX INC. |
| Manufacturer Address | 34 THIRD AVENUE BURLINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2013-10-10 |