MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-19 for TVC INSIGHT CATHETER TVC-C195-20 manufactured by Infraredx Inc..
[19199730]
Pt presented for pci. During procedure, infraredx catheter was prepped according to ifu. It was inserted into the om2 and at that time the fellow noticed the pt had no pressure. Doctor tightened the touhy and still no pressure on the monitor. He decided to proceed with pullback. The results were outliers, indicative of air in either the catheter or vessel. The pt began crashing at this time and the catheter was removed. After intubation and cpr, doctor took a quick angiogram and the vessel was closed. Doctor intervened, using an export catheter and medication. Pt stabilized. Doctor confirmed vessel was open. Doctor believes root cause to be an air embolus and not catheter.
Patient Sequence No: 1, Text Type: D, B5
[19389524]
Catheter was returned to manufacturer for investigation. Upon receipt, catheter was inspected for any visual or manufacturing defects. None found. Catheter was then tested on a test bed and found to be fully functional, producing functional chemograms and ivus info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004722468-2013-00004 |
| MDR Report Key | 3503544 |
| Report Source | 07 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-11-16 |
| Date of Event | 2013-10-16 |
| Date Mfgr Received | 2013-10-17 |
| Date Added to Maude | 2013-12-12 |
| 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 | 0 |
| 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 | 2013-11-19 |
| Model Number | TVC-C195-20 |
| Lot Number | 304242-A |
| Device Expiration Date | 2014-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INFRAREDX INC. |
| Manufacturer Address | 34 THIRD AVENUE BURLINGTON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2013-11-19 |