CROSSER IQ ULTRASONIC
Received Jan 7, 2026 · Event occurred Dec 13, 2025
Report 2020394-2025-02344 · MDR key 23988244
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKU1172
Product problems
- Peeled/Delaminated
- Detachment of Device or Device Component
Patient
NA · 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 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.
Description of Event or Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER TIP WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.
Description of Event or Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER TIP WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.
Additional Manufacturer Narrative
H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: RECEIVED ONE DEVICE FOR EVALUATION. UPON VISUAL INSPECTION, THE TITANIUM TIP WAS NOTED TO BE DETACHED FROM THE CATHETER. NO ANOMALIES NOTED TO THE REST OF THE CATHETER AND HANDLE. MARKER BAND WAS PRESENT AND HAD PEELING OF THE SHEATH OVER IT. THE INNER GUIDEWIRE LUMEN WAS EXPOSED AT THE DISTAL END OF THE CATHETER AND APPEARED DAMAGED. CORE WIRE WAS EXPOSED AT THE DISTAL END OF THE DETACHMENT. MICROSCOPIC IMAGES WERE TAKEN OF THE DISTAL TIP OF THE CATHETER AND TITANIUM TIP. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO DETACHMENT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DETACHMENT AS THE TITANIUM TIP WAS NOTED TO BE DETACHED AND ALSO THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELING AS THE MARKER BAND WAS PRESENT AND HAD PEELING OF THE SHEATH OVER IT. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DETACHMENT AND IDENTIFIED PEELING COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. D4 (UNIQUE IDENTIFIER (UDI) #), G3, H6 (DEVICE, COMPONENT, METHOD, RESULT, CONCLUSION). 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.