CROSSER IQ ULTRASONIC
Received Sep 8, 2025 · Event occurred Aug 15, 2025
Report 2020394-2025-01431 · MDR key 22990459
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKN2799
Product problems
- Material Separation
- Detachment of Device or Device Component
- Material Deformation
- Material Separation
- Detachment of Device or Device Component
- Material Deformation
Patient
NA · Unknown
- 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 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) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE IN IPSILATERAL BK TREATMENT. DURING PROCEDURE, MISALIGNMENT WAS ALLEGEDLY FOUND BETWEEN THE TIP AND THE CATHETER BODY. 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: ONE CTO DEVICE WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, MARKER BAND IS PRESENT AND UNDAMAGED, SALINE WAS PRESENT OVER IT. MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHEATH. THE SHEATH PROXIMAL TO THE MARKER BAND WAS BUNCHED AS WELL. NO FUNCTIONAL EVALUATION WAS PERFORMED DUE TO THE MATERIAL SEPARATION. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL SEPARATION AS THE SEPARATION WAS NOTED BETWEEN THE CATHETER SHAFT AND TIP. ALSO, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION AS THE SHEATH PROXIMAL TO THE MARKER BAND NOTED TO BE BUNCHED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL SEPARATION AND IDENTIFIED DEFORMATION 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. G3, H6 (DEVICE, COMPONENT, 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) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE IN IPSILATERAL BK TREATMENT. DURING PROCEDURE, MISALIGNMENT WAS ALLEGEDLY FOUND BETWEEN THE TIP AND THE CATHETER BODY. THERE WAS NO REPORTED PATIENT INJURY.