VEIN360 REPROCESSED PHILLIPS VOLCANO IVUS CATHETER
Received Jun 20, 2026 · Event occurred May 14, 2026
Report 3032391-2026-00040 · MDR key 25570209
Device
Generic name
Visions Pv .014p Rx Digital Ivus 150
Manufacturer
Medline RenewalCatalog number
014RRH
Lot number
300005383971-384371
Product problems
- Failure to Advance
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, THE IVUS CATHETER WOULD NOT TRACK OVER THE WIRE. THE CATHETER WAS BEING USED TO TRACK OVER A GUIDEWIRE AND OCCURRED BEFORE ENTERING THE SHEATH. NEW IVUS WAS OPENED AND CASE PROCEEDED.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE IVUS CATHETER WOULD NOT TRACK OVER THE WIRE. THE CATHETER WAS BEING USED TO TRACK OVER A GUIDEWIRE AND OCCURRED BEFORE ENTERING THE SHEATH. NEW IVUS WAS OPENED AND CASE PROCEEDED. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.