CROSSER

Additional Manufacturer Narrative

H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE CROSSER RECANALIZATION CATHETER PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE CROSSER RECANALIZATION CATHETER PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: ONE ELECTRONIC PHOTO WAS RECEIVED AND REVIEWED. THE PHOTO SHOWS A HEALTHCARE PROFESSIONAL (HCP) HOLDING THE TRANSDUCER HANDLE ALONG WITH THE STRAIN RELIEF INSIDE THE TRANSPARENT PACKAGING. WATER DROPLETS ARE VISIBLE THROUGHOUT THE DEVICE WITHIN THE PACKAGING. NO OTHER ANOMALIES WERE NOTED. RECEIVED ONE 14S CROSSER CTO RECANALIZATION CATHETER FOR EVALUATION. NO ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. A COMPLETE CIRCUMFERENTIAL BREAK WAS NOTED BETWEEN THE PROXIMAL PORTION OF THE CATHETER SHAFT AND THE STRAIN RELIEF. THE INNER GUIDEWIRE LUMEN WAS VISIBLE AND STILL CONNECTED. MARKER BAND IS PRESENT AND UNDAMAGED. NO OTHER VISUAL ANOMALIES WERE OBSERVED. DURING FUNCTIONAL TESTING: THE CROSSER WAS CONNECTED TO THE CROSSER AND FLOW MATE AND THE DEVICE ACTIVATED SUCCESSFULLY AND WATER LEAKS WERE NOTED AT THE STRAIN RELIEF OF THE CATHETER. WATER WAS NOT OBSERVED TO EXIT THE DISTAL TIP. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED LEAK AT THE STRAIN RELIEF. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK BETWEEN PROXIMAL CATHETER SHAFT AND THE STRAIN RELIEF. THE OBSERVED STRUCTURAL BREAK IS CONSIDERED THE LIKELY CAUSE OF THE REPORTED LEAKAGE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED LEAK AND IDENTIFIED BREAK 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, PRIOR TO A RECANALIZATION PROCEDURE CROSSER USING THE CATHETER. PRIOR TO THE PROCEDURE, THE CROSSER WAS ALLEGEDLY LEAKING AT CATHETER BASE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.