MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-07 for TVC INSIGHT CATHETER TVC-C195-20 manufactured by Infraredx, Inc..
[100006545]
Patient Sequence No: 1, Text Type: N, H10
[100006546]
For #13 and #15 tandem lesions, ultimaster 3. 5x12, 2. 5x12 was implanted then oct was performed. Since the distal edge of the stent for #13 was not joining well to the vessel wall, oct catheter was caught during removal, but the catheter was successfully removed. Then, tvc catheter was inserted; however it was unable to reach #15. Therefore attempted a pullback from #13 stenting area to the proximal, however it was stuck at the stent distal edge and pullback failed. The operator tried the catheter to push to distal with applying torque however it did not advance. Therefore cut off the catheter shaft and removed the imaging core and ragiforcus guide wire0. 018 was inserted inside the catheter. However it did not advance further coronary ostium and applied torque in this condition but the situation did not change. Next, the proximal end of the same radiforcus was inserted; it passed differently from the catheter shaft at the coronary ostium. It was considered if gw broke through the catheter shaft and then removed. Also the operator attempted guideliner 5. 5 but it also failed insertion. Lastly attempted to push the catheter only to the distal and applied torque and pulled, catheter was removed finally. Deformation was confirmed at the distal edge of the stent but another inflation was taken by hp balloon and the procedure was completed. The cause of the stuck was probably the stent edge, the operator is requesting to confirm the cause and about investigate 0. 018gw insertion failure. Also please investigate if 0. 018 gw broke through the catheter shaft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004722468-2017-00005 |
| MDR Report Key | 7249709 |
| Date Received | 2018-02-07 |
| Date of Report | 2018-02-07 |
| Date of Event | 2017-12-20 |
| Date Facility Aware | 2018-01-10 |
| Report Date | 2018-01-10 |
| Date Reported to Mfgr | 2018-01-10 |
| Date Mfgr Received | 2018-01-10 |
| Device Manufacturer Date | 2017-03-16 |
| Date Added to Maude | 2018-02-07 |
| 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 | TVC INSIGHT CATHETER |
| Generic Name | ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER |
| Product Code | OGZ |
| Date Received | 2018-02-07 |
| Returned To Mfg | 2018-01-16 |
| Model Number | TVC-C195-20 |
| Lot Number | G48652 |
| Device Expiration Date | 2018-09-16 |
| 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 | 2018-02-07 |