CROSSER IQ

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: RECEIVED ONE CROSSER IQ ULTRASONIC CTO DEVICE FOR EVALUATION. THE DISTAL PORTION OF THE SALINE TUBING WAS OBSERVED TO BE DISCONNECTED AT THE STOPCOCK AND WAS RETURNED SEPARATELY. NO ANOMALIES WERE NOTED TO THE TRANSDUCER HANDLE AND SALINE HUB. A FRACTURE WAS IDENTIFIED AT THE GUIDEWIRE PORT, WITH WHAT APPEARED TO BE DRY SALINE RESIDUE PRESENT WITHIN THE SAME REGION. THE MARKER BAND WAS PRESENT AND UNDAMAGED. NO ANOMALIES WERE OBSERVED AT THE DISTAL TIP; HOWEVER, UNKNOWN HAIR LIKE FIBERS WERE NOTED. SALINE WAS OBSERVED WITHIN THE SALINE DRIP CHAMBER. DUE TO THE RETURNED CONDITION OF THE DEVICE, FUNCTIONAL TESTING WAS NOT PERFORMED. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY AS NO FUNCTIONAL TESTING WAS PERFORMED. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK AT THE GUIDEWIRE PORT AND ALSO THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION AT THE DISTAL TIP. A DEFINITIVE ROOT CAUSE FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY, IDENTIFIED BREAK AND MATERIAL DEFORMATION 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. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD 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 USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY DID NOT PASS THROUGH THE EXIT PORT OF THE CATHETER AND STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.