CROSSER IQ ULTRASONIC
Received Mar 16, 2026 · Event occurred Feb 20, 2026
Report 2020394-2026-00650 · MDR key 24603330
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKU2406
Product problems
- Material Separation
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER WAS ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Additional Manufacturer Narrative
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.