ZEBRA

Description of Event or Problem

DURING A STROKE THROMBECTOMY PROCEDURE PERFORMED VIA FEMORAL ACCESS, THE PHYSICIAN OBSERVED SEPARATION AT THE HUB-HYPOTUBE INTERFACE OF A ZEBRA CATHETER WHILE PREPARING TO PERFORM A THIRD PASS WITH A STENT RETRIEVER. THE THIRD PASS WAS NOT PERFORMED. THE STENT RETRIEVER AND ZEBRA CATHETER WERE REMOVED TOGETHER TO PREVENT FURTHER SEPARATION OR POTENTIAL FRACTURE PROGRESSION. NO PATIENT INJURY, PROLONGED PROCEDURE, OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. THE PHYSICIAN CONFIRMED THE PATIENT OUTCOME WAS STABLE. EVALUATION OF THE RETURNED DEVICE CONFIRMED A FRACTURE AT THE DISTAL EDGE OF THE STRAIN RELIEF AT THE HUB-HYPOTUBE INTERFACE. THE DAMAGE WAS LOCALIZED TO THE HUB REGION. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL COIL SPACING OR PITCH VARIATION, AND THE DISTAL TIP SHOWED NO ABNORMALITIES. THE OBSERVED DEFORMATION MORPHOLOGY IS CONSISTENT WITH MECHANICAL OVERSTRESS INVOLVING COMBINED BENDING AND TORSIONAL LOADING AT THE HUB-HYPOTUBE INTERFACE. DESPITE THE VISIBLE FRACTURE, THE CENTRAL LUMEN WAS ABLE TO BE FLUSHED WHEN THE FRACTURED REGION WAS TEMPORARILY COVERED, AND NO ADDITIONAL BREACHES WERE IDENTIFIED ALONG THE SHAFT. NO EVIDENCE OF MATERIAL DEFECT, MANUFACTURING NONCONFORMANCE, OR SYSTEMIC DESIGN DEFICIENCY WAS IDENTIFIED.