MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-07-18 for TVC INSIGHT CATHETER TVC-C195-22 manufactured by Infraredx Inc..
[18092156]
Patient presented with moderate to severe circumflex lesion by angio and ivus. No other severe coronary disease. Left heart cath, coronary angios performed percutaneously via right groin. Ivus of circumflex to assess a moderate to severe lesion. While ivus was placed, procedure complicated by cardiac arrest and hypotension requiring 50 minutes resuscitation. Patient was transferred to ccu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004722468-2014-00001 |
| MDR Report Key | 3954760 |
| Report Source | 99 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-06-24 |
| Date Mfgr Received | 2014-06-24 |
| Date Added to Maude | 2014-07-25 |
| 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 |
| 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 CENTER |
| Product Code | OGZ |
| Date Received | 2014-07-18 |
| Model Number | TVC-C195-22 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Life Threatening | 2014-07-18 |