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TVC Insight™ TVC-C195-20Recalls & reported problems

Nipro Vascular Innovations Americas, Inc. · Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer. Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857595006203), received between Nov 10, 2017 and Nov 10, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Physical Resistance1

Patient problems

  • Thrombus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 10, 2017Physical Resistance

    PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THROMBUS WAS FORMED IN THE LAD WHILE ATTEMPTING TO CROSS A LESION WITH THE NIRS-IVUS CATHETER. THE CATHETER WAS REMOVED AND THE THROMBUS WAS ASPIRATED WITH AN ASPIRATION CATHETER TO RESTORE BLOOD FLOW. NO FURTHER ATTEMPT WAS MADE TO USE THE NIRS-IVUS CATHETER FOLLOWING ASPIRATION. OPERATOR REPORTED FEELING RESISTANCE WHILE ATTEMPTING TO CROSS THE LESION THROUGH THE TORTUOUS VESSEL, POSSIBLY HARMING THE INTIMA AND CAUSING A THROMBUS.

    Patient problems: Thrombus

    MAUDE report 7023059 ↗

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Sources and updates

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