FDA Adverse Event Malfunction Summary report: N

VIS-RX PRIME MICRO-IMAGING CATHETER

MDR report key: 25334580 · Received May 29, 2026

Report

Report Number: 3011578544-2026-00036
Event Type: Malfunction
Date Received: May 29, 2026
Date of Event: December 5, 2025
Report Date: December 5, 2025
Manufacturer: GENTUITY, LLC
Product Code: DQO
PMA / PMN Number: K242966
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

DURING A TIGHT LCX PULLBACK THE PIM JAWS RELEASED PRODUCING REPETITIVE FRAMES; READVANCE PRODUCED A KNOCKING SOUND AND THE CATHETER WAS DISCONNECTED. RETURNED UNIT TESTING REPRODUCED THE KNOCKING ON READVANCE AND THERE WAS MINOR DAMAGE TO THE CATHETER'S PULLER ARM. ADDITIONALLY, THE CATHETER HAD VISIBLE KINKS. THE CAUSE OF THE KNOCKING IS UNDETERMINED. COMPLAINT IS CONFIRMED.

Description of Event or Problem · 0

PHYSICIAN ATTEMPTED PRE-IMAGING IN A TIGHT LCX. DURING PULLBACK WE HEARD THE SNAPPING SOUND OF THE PIM JAWS RELEASING BUT DID NOT LOSE OUR IMAGE, JUST ENDED UP WITH REPETITIVE FRAMES. ON READVANCE I WAS NOT QUICK ENOUGH TO STOP PIM BEFORE KNOCKING SOUND BEGAN. I FOLLOWED THE ON SCREEN PROPS OF DISCONNECTING THE CATHETER. DUE TO DISCONNECTING I WAS UNABLE TO SEE IF THE RED LIGHT WAS ON IN THE CATHETER. WE ASSESSED THE IMAGE TO DEVELOP A PLAN TO PRE TREAT. THE PULLBACK APPEARS TO HAVE GONE ALMOST 40MM BEFORE THE JAWS RELEASED. THE CATHETER WAS REHOOPED AND HANDED OFF TO BE BAGGED. QUICK INSPECTION OF THE CATHETER SHOWS THAT THE AFL DID NOT TRIP AND CATHETER APPEARS TO BE REHOMED BY THE PIM DESPITE THE JAWS RELEASING IT. I HANDED OFF A SECOND CATHETER AND THAT PERFORMED 5 PULLBACKS WITHOUT ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
465294	VIS-RX PRIME MICRO-IMAGING CATHETER	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	GENTUITY, LLC	G31-01	25K1700

Patients

Seq	Age	Sex	Outcome	Treatment
1