MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-08-29 for DUALPRO? IVUS+NIRS IMAGING CATHETER TVC-C195-42 manufactured by Infraredx, Inc..
[118557438]
Percutaneous coronary intervention. Diagnostic imaging with a combination near-infrared spectroscopy (nirs) and intravascular ultrasound (ivus) catheter. A first imaging catheter was used to scan a coronary artery. A 90 degree-size wedge of the transverse ivus image was observed to be missing during the scan. A second catheter was tried and a missing wedge of the transverse ivus image was again observed during the scan. A different brand of ivus imaging catheter was then used to scan the vessel. A dissection of the vessel was observed during scanning and a stent was deployed to treat it. While the nirs-ivus catheter was not deemed to be the direct cause of patient harm, failure of the ivus imaging with the nirs-ivus catheter complicated the procedure and may have contributed to user error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004722468-2018-00002 |
| MDR Report Key | 7826579 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-01 |
| Date Facility Aware | 2018-08-08 |
| Report Date | 2018-08-08 |
| Date Reported to Mfgr | 2018-08-08 |
| Date Mfgr Received | 2018-08-10 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2018-08-29 |
| 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 | 3 |
| Brand Name | DUALPRO? IVUS+NIRS IMAGING CATHETER |
| Generic Name | ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER |
| Product Code | OGZ |
| Date Received | 2018-08-29 |
| Returned To Mfg | 2018-08-13 |
| Model Number | TVC-C195-42 |
| Lot Number | 804191 |
| Device Expiration Date | 2018-10-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-08-29 |