CROSSER IQ ULTRASONIC
Received Apr 30, 2026 · Event occurred Apr 9, 2026
Report 2020394-2026-01061 · MDR key 25039182
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKW0868
Product problems
- Material Separation
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, IN A POP CASE, THE CATHETER TIP WAS ALLEGEDLY DETACHED AFTER FIFTEEN SECONDS PASSING THROUGH THE GUIDEWIRE BUT STILL ATTACHED TO THE CORE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. 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 DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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.