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..
[16008358]
Patient was admitted with progressive chest pain for staged pci of proximal ramus branch. Underwent pci and during procedure had a plaque shift to the lad requiring complicated bifurcation pci. This was further complicated by abrupt closure during pci of lm putting patient in cardiogenic shock. Patient went into cardiac arrest following insertion of balloon catheter, tvc insight catheter, removal of tvc insight catheter, balloon inflation (6atm for 7 secs), and removal of balloon catheter. Thrombus detected in lm. Required emergent lm stenting in an unprotected manner. Impella placed and pci restored left coronary flow. Post procedure massive exsanguination from l access site as groin hematoma and retroperitoneal bleed noted. Underwent emergent vascular repair of l femoral artery. Post impella removal, r leg became compromised requiring surgical repair and thrombectomy. She also underwent cooling protocol for cardiac arrest. Conclusions: successful angioplasty of l circumflex lesion but complicated by lm dissection, the lad, and cardiac arrest. Successful impella implantation. Successful salvage angioplasty of the lm, lad, and cx.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004722468-2013-00003 |
| MDR Report Key | 3412998 |
| Report Source | 07 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-10-10 |
| Date of Event | 2013-05-30 |
| 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 | 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 | 2013-10-10 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2013-10-10 |