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. INVESTIGATION SUMMARY: RECEIVED ONE CTO RECANALIZATION CATHETER FOR EVALUATION. UPON VISUAL EVALUATION NO ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. MARKER BAND IS PRESENT AND UNDAMAGED. UNDER MICROSCOPIC EXAMINATION, A COMPLETE COMPOUND BREAK WAS NOTED DISTAL TO THE STRAIN RELIEF ON THE OUTER CATHETER SHAFT. BOTH ENDS OF THE COMPLETE COMPOUND BREAK WERE NOTED TO BE JAGGED. THE PROXIMAL END OF THE OUTER CATHETER, DISTAL TO THE COMPLETE BREAK WAS DAMAGED. NO FUNCTIONAL TESTING PERFORMED DUE TO MATERIAL DEFORMATION PRESENT ON THE CATHETER. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED LEAK AS NO FUNCTIONAL TESTING PERFORMED DUE TO RETURNED CONDITION OF THE DEVICE. HOWEVER, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK AND MATERIAL DEFORMATION AS A COMPLETE COMPOUND BREAK WAS NOTED DISTAL TO THE STRAIN RELIEF ON THE OUTER CATHETER SHAFT. BOTH ENDS OF THE COMPLETE COMPOUND BREAK WERE NOTED TO BE JAGGED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED LEAK AND 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

A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER. DURING THE PROCEDURE, THE CROSSER WAS ALLEGEDLY HAVING A POOR CONNECTION PROBLEM BETWEEN THE HANDLE PORTION AND CATHETER; WATER SPURTS OUT WHEN FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.