FDA Adverse Event Malfunction Summary report: N

VIS-RX PRIME MICRO-IMAGING CATHETER

MDR report key: 25321593 · Received May 28, 2026

Report

Report Number: 3011578544-2026-00032
Event Type: Malfunction
Date Received: May 28, 2026
Date of Event: April 17, 2025
Report Date: April 17, 2025
Manufacturer: GENTUITY, LLC
Product Code: DQO
UDI-DI: 00859910007055
PMA / PMN Number: K242966
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

CALIBRATION FAILURE INCONCLUSIVE. INVESTIGATION FOUND A BUCKLED SECTION OF HEAT-SHRINK FROM THE PHILIPS OMNI-WIRE LODGED IN THE RX TIP. COMPARATIVE PHILIPS OMNI-WIRE SAMPLES SHOWED THE WIRE ASSOCIATED WITH THE COMPLAINT HAD ABNORMALLY LARGE RAISED EDGES. GUIDEWIRE DEFECT CAUSED THE ENTRAPMENT; GENTUITY WILL MONITOR FOR RECURRENCE.

Description of Event or Problem · 0

1) FIRST PRIME CASE BEING DONE IN THE CIRC WITH DR. (B)(6), AND CALIBRATION FAILED, IT JUST CONTINUED, AND NEVER TIMED OUT WITH THE CALIBRATION FAILURE MESSAGE, SO WE HAD TO MANUALLY STOP AFTER WAITING ABOUT 3 TIMES LONGER THAN USUAL. THE VESSEL WAS NOT VERY TORTUOUS, OR HEAVILY CALCIFIED, AND ALSO HAD A NEGATIVE FFR AT 0.95. 2) AS HE SLOWLY PULLED THE CATHETER OUT OF THE BODY WHILE LOOKING FOR A KINK OR FIBER BREAK, THE CATHETER GOT STUCK ON THE WIRE (PHILIPS OMNI-WIRE, THEIR PRESSURE WIRE). HE WAS NOT ABLE TO FREE THE CATHETER, SO WAS FORCED TO PULL THE CATHETER AND WIRE TOGETHER. THERE WAS NO PT COMPLICATION. HE THEN ASKED FOR A NEW INTERVENTIONAL WIRE (RUNTHROUGH) AND A NEW PRIME CATHETER AND WAS ABLE TO GET A SUCCESSFUL PULLBACK. LOGS AND SUCCESSFUL OCT HAVE BEEN UPLOADED TO BOX, AND CATHETER IS BEING RETURNED (STILL ON PHILIPS OMNI-WIRE).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
363745	VIS-RX PRIME MICRO-IMAGING CATHETER	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	GENTUITY, LLC	G31-01	25C1700	00859910007055

Patients

Seq	Age	Sex	Outcome	Treatment
1