CROSSER IQ ULTRASONIC
Received Dec 23, 2025 · Event occurred Dec 1, 2025
Report 2020394-2025-02222 · MDR key 23874981
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKU0465
Product problems
- Improper or Incorrect Procedure or Method
- Material Deformation
- Unintended Movement
- Improper or Incorrect Procedure or Method
- Material Deformation
- Unintended Movement
Patient
NA · Unknown
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
- Foreign Body In Patient
- 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 RECORDS WAS PERFORMED. THE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F ¿ THE INFORMATION PROVIDED 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) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER TIP ALLEGEDLY DEVIATED FROM THE GUIDEWIRE PATH. IT WAS FURTHER REPORTED THAT THE NON-BD GUIDEWIRE HAD BROKEN AND ATTEMPTS TO RETRIEVE THE BROKEN WIRE WERE UNSUCCESSFUL AND IT REMAINED IN PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN
Additional Manufacturer Narrative
H11: ADDITIONAL INFORMATION WAS RECEIVED AND THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE NO LONGER REPORTABLE. SINCE AN INITIAL MDR WAS SUBMITTED, THEREFORE, THE FILE WILL REMAIN ASSESSED AS A MALFUNCTION. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. G2, G3, H1 (DEVICE). SECTION A THROUGH F ¿ THE INFORMATION PROVIDED 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) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER TIP ALLEGEDLY DEVIATED FROM THE GUIDEWIRE PATH. IT WAS FURTHER REPORTED THAT THE NON BD GUIDEWIRE HAD BROKEN AND IT REMAINED IN PATIENT. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS EXTENDED BEYOND THE CROSSER IQ DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Description of Event or Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER TIP ALLEGEDLY DEVIATED FROM THE GUIDEWIRE PATH. IT WAS FURTHER REPORTED THAT THE NON-BD GUIDEWIRE HAD BROKEN AND IT REMAINED IN PATIENT. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS EXTENDED BEYOND THE CROSSER IQ DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Additional Manufacturer Narrative
H11: ADDITIONAL INFORMATION WAS RECEIVED, STATING THAT THE GUIDEWIRE WAS EXTENDED BEYOND THE CROSSER IQ DEVICE AND HENCE THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS MALFUNCTION. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. B1, B2, B5, G3, H1, H6 (DEVICE, PATIENT). SECTION A THROUGH F: THE INFORMATION PROVIDED 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.