MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for DUALPRO? IVUS+NIRS IMAGING CATHETER TVC-C195-42 manufactured by Infraredx, Inc..
[114706419]
Patient Sequence No: 1, Text Type: N, H10
[114706420]
Percutaneous coronary intervention. Diagnostic imaging with a combination near-infrared spectroscopy (nirs) and intravascular ultrasound (ivus) catheter. After performing a 5th scan with the imaging catheter, it was reported that it was difficult to withdraw the catheter from the vessel. Several approaches were taken to remove the catheter, including 1-pushing and pulling the catheter, 2- inserting a balloon or micro catheter adjacent to the imaging catheter, 3- translating the imaging core proximally (during live ivus imaging), and 4- cutting the sheath to remove the imaging core and inserting a 0. 018" guidewire. The latter approach was ultimately successful in removing the imaging catheter from the vessel. Note that ivus imaging was lost and the imaging core was nearly detached in the course of attempting to withdraw the catheter. A review of the ivus data indicates that a stent was deployed in the mid/distal vessel and another overlapping stent was deployed in the proximal vessel during the procedure prior to the catheter becoming stuck. Ivus images of the second stent suggest that the stent was mal-apposed to the vessel wall. This mal-apposition may have caused the imaging catheter to become stuck in the stented vessel. No injury to patient reported. No treatment of patient required due to malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004722468-2018-00001 |
| MDR Report Key | 7696102 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-06-28 |
| Date Facility Aware | 2018-07-09 |
| Report Date | 2018-07-09 |
| Date Reported to Mfgr | 2018-07-09 |
| Date Mfgr Received | 2018-07-10 |
| Device Manufacturer Date | 2018-03-20 |
| Date Added to Maude | 2018-07-17 |
| 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 | 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 Code | OGZ |
| Date Received | 2018-07-17 |
| Model Number | TVC-C195-42 |
| Lot Number | 803201 |
| Device Expiration Date | 2018-09-20 |
| Device Availability | Y |
| Device Age | 3 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 917934414 US 917934414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-17 |