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 CTO RECANALIZATION CATHETERS PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE CROSSER CTO RECANALIZATION CATHETERS PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATIONAL SUMMARY: RECEIVED ONE 14S CROSSER CTO RECANALIZATION CATHETER FOR EVALUATION. UPON VISUAL INSPECTION, THE SONIC CONNECTOR WAS OBSERVED PROTRUDING FROM THE PROXIMAL END OF THE TRANSDUCER HANDLE. NO ANOMALIES WERE NOTED WITH THE SALINE HUB. THE MARKER BAND WAS PRESENT AND UNDAMAGED. TWISTING WAS OBSERVED ALONG THE DISTAL PORTION OF THE CATHETER SHAFT. DURING FUNCTIONAL TESTING, AN IN-HOUSE SYRINGE WAS ATTACHED TO THE SALINE HUB AND THE DEVICE WAS FLUSHED WITH WATER. LEAKAGE WAS OBSERVED AT THE STRAIN RELIEF, WHILE FLUID EXITED FROM THE DISTAL TIP. A PARTIAL CIRCUMFERENTIAL BREAK WAS NOTED BETWEEN THE PROXIMAL PORTION OF THE CATHETER SHAFT AND THE STRAIN RELIEF. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED LEAK AT THE STRAIN RELIEF. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL TWISTED/BENT LONG THE DISTAL PORTION OF THE CATHETER SHAFT AND ALSO 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, IDENTIFIED BREAK AND IDENTIFIED MATERIAL TWISTED/BENT 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, THE PATIENT WAS PREPPED FOR A RECANALIZATION PROCEDURE USING A CROSSER CATHETER. PRIOR TO THE PROCEDURE, SALINE WAS REPORTEDLY LEAKING FROM THE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.