CROSSER IQ
Received Feb 10, 2026 · Event occurred Jan 14, 2026
Report 2020394-2026-00220 · MDR key 24302056
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKN2778
Product problems
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. ONE FLUOROSCOPIC VIDEO WAS PROVIDED AND REVIEWED. THE VIDEO DEMONSTRATES THE DEVICE IN THE BELOW KNEE POPLITEAL ARTERY. THERE IS A WIRE IN THE DEVICE PROXIMAL TO THE TIP. THE WIRE AND DEVICE ARE PASSED TOGETHER IN A NORMAL FASHION. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED FAILURE AS THE VIDEO SHOWS NORMAL OCCURRENCE WITH THE DEVICE USE. THERE WERE NO ABNORMALITIES IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED UNINTENDED MOVEMENT 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 (METHOD, RESULT, CONCLUSION). 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 BY USING THE CROSSER IQ CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE HEAD/BODY ALLEGEDLY MOVED FORWARD OUT OF POSITION AT TIMES. 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 NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, VIDEOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BY USING THE CROSSER IQ CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE HEAD/BODY ALLEGEDLY MOVED FORWARD OUT OF POSITION AT TIMES. THERE WAS NO REPORTED PATIENT INJURY.