Description of Event or Problem · 0
DURING A NEUROVASCULAR PROCEDURE, A ZEBRA 6 FR CATHETER (FG 01194-01, LOT FG250917C-02) WITH A SIM2 DISTAL CONFIGURATION WAS REPORTEDLY USED FOR VASCULAR ACCESS. DURING THE PROCEDURE, THE DISTAL SIM2 TIP SEGMENT REPORTEDLY SEPARATED FROM THE CATHETER. LIMITED PROCEDURAL DETAILS WERE AVAILABLE AT THE TIME OF MDR SUBMISSION DESPITE FOLLOW-UP ATTEMPTS WITH THE SALES REPRESENTATIVE AND PHYSICIAN. NO ADDITIONAL INFORMATION REGARDING THE EXACT PROCEDURAL SEQUENCE, RESISTANCE ENCOUNTERED, PATIENT OUTCOME, OR RETRIEVAL DETAILS WAS AVAILABLE. ONLY THE SEPARATED SIM2 DISTAL TIP SEGMENT WAS RETURNED FOR EVALUATION. RETURNED PRODUCT ANALYSIS IDENTIFIED COMPLETE SEPARATION OF THE DISTAL TIP SEGMENT WITH MEASURED ELONGATION OF APPROXIMATELY 4.5 CM RELATIVE TO NOMINAL MANUFACTURED LENGTH, CONSISTENT WITH SIGNIFICANT TENSILE LOADING PRIOR TO SEPARATION. NO EVIDENCE OF MANUFACTURING OR MATERIAL NONCONFORMANCE WAS IDENTIFIED IN THE RETURNED SEGMENT EVALUATION. THE OBSERVED DAMAGE MORPHOLOGY WAS CONSISTENT WITH MECHANICAL OVERSTRESS ENCOUNTERED DURING CLINICAL USE. AT THE TIME OF THIS REPORT, NO ADDITIONAL PATIENT INJURY INFORMATION HAD BEEN PROVIDED.