MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-09 for DUALPRO IVUS + NIRS IMAGING CATHETER TVC-C195-42 manufactured by Infraredx, Inc..
[96962044]
Percutaneous coronary intervention of the right coronary artery (rca). Diagnostic imaging with a combination near-infrared spectroscopy (nirs) and intravascular ultrasound (ivus) catheter. Difficulty encountered in removing the catheter from the artery after scanning the stented lesion. Pre-stent: catheter crossed heavily calcifed lesion smoothly. Post-stent (3. 00 x 38 mm): attempted to scan stented lesion with imaging catheter. Catheter became stuck in stented coronary artery. Unable to insert balloon or micro-catheter to remove imaging catheter. Used extra floppy guidewire to successfully remove the imaging catheter from the coronary artery. Review of angiographic and nirs-iuvs data suggests that a segment of under-expanded stent may have contributed to the imaging catheter becoming stuck in the stented coronary artery. No injury to patient reported. No treatment of patient required due to adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004722468-2017-00004 |
| MDR Report Key | 7177199 |
| Date Received | 2018-01-09 |
| Date of Report | 2018-01-09 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-13 |
| Device Manufacturer Date | 2017-09-14 |
| Date Added to Maude | 2018-01-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN SUM |
| Manufacturer Street | 34 THIRD AVE |
| Manufacturer City | BURLINGTON MA 018034414 |
| Manufacturer Country | US |
| Manufacturer Postal | 018034414 |
| Manufacturer Phone | 7813459651 |
| Manufacturer G1 | INFRAREDX, INC. |
| Manufacturer Street | 34 THIRD AVE |
| Manufacturer City | BURLINGTON MA 018034414 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 018034414 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DUALPRO IVUS + NIRS IMAGING CATHETER |
| Generic Name | ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER, PRODUCT |
| Product Code | OGZ |
| Date Received | 2018-01-09 |
| Returned To Mfg | 2017-12-22 |
| Model Number | TVC-C195-42 |
| Lot Number | 709142 |
| Device Expiration Date | 2018-03-14 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INFRAREDX, INC. |
| Manufacturer Address | 34 THIRD AVE BURLINGTON MA 018034414 US 018034414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-09 |