Crosser iQ Ultrasonic
Received Apr 22, 2026 · Event occurred Mar 30, 2026
Report 2020394-2026-00995 · MDR key 24950047
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKU0464
Product problems
- Material Separation
- Failure to Advance
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD WAS 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.
Description of Event or Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE VIA AN IPSILATERAL APPROACH USING THE CROSSER. DURING THE PROCEDURE, THE CATHETER DID NOT PASS THROUGH. IT WAS FURTHER REPORTED THAT THE TIP HAD SNAPPED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.