CROSSER IQ ULTRASONIC

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. UPON VISUAL EVALUATION AND MICROSCOPIC VISUAL OBSERVATION. NO ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. THE MARKER BAND IS PRESENT AND DID NOT APPEAR DAMAGED. MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHEATH. DAMAGE WAS NOTED ON THE DISTAL END OF THE CATHETER SHEATH. THE INNER GUIDEWIRE LUMEN WAS EXPOSED AND STILL ATTACHED TO THE CATHETER SHEATH. DUE TO THE RECEIVED CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING WAS PERFORMED. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED DEVICE DEVICE INCOMPATIBILITY AS NO FUNCTIONAL TESTING WAS PERFORMED. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION BETWEEN THE DISTAL TIP AND CATHETER SHEATH, AND THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION ON THE DISTAL END OF THE CATHETER SHEATH. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY, IDENTIFIED MATERIAL DEFORMATION AND MATERIAL SEPARATION COULD NOT BE DETERMINED BASED ON 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, THE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. PRIOR TO THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY FAILED TO ADVANCE OVER THE GUIDE WIRE LUMEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.