CROSSER IQ ULTRASONIC
Received Aug 25, 2025 · Event occurred Jul 26, 2025
Report 2020394-2025-01325 · MDR key 22881797
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKR1647
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
55 YR · Female
- No Clinical Signs, Symptoms or Conditions
- 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 WILL BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. 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) 2025, A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER IQ CATHETER. DURING THE PROCEDURE, A PIECE OF THE CATHETER WAS DETACHED. IT WAS FURTHER REPORTED THAT A SNARE WAS USED TO RETRIEVE THE FOREIGN OBJECT. 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: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DETACHMENT COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELLING 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 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) 2025, A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER IQ CATHETER. DURING THE PROCEDURE, A PIECE OF THE CATHETER WAS DETACHED. IT WAS FURTHER REPORTED THAT A SNARE WAS USED TO RETRIEVE THE FOREIGN OBJECT. THERE WAS NO REPORTED PATIENT INJURY.