THE MARATHON CATHETER WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. AS NOTED IN THE MARATHON IFU: ?INFUSION PRESSURE WITH THIS DEVICE SHOULD NOT EXCEED 690 KPA/100 PSI. PRESSURE IN EXCESS OF 690 KPA/100 PSI MAY RESULT IN CATHETER RUPTURE, POSSIBLY RESULTING IN PATIENT INJURY. REMOVE EXCESS SLACK IN THE CATHETER TO REDUCE THE POTENTIAL FOR CATHETER KINK OR PROLAPSE. VERIFY CATHETER INTEGRITY PRIOR TO RE-INSERTING GUIDEWIRE OR INJECTING EMBOLIC MATERIAL TO PREVENT VASCULAR DAMAGE OR UNINTENDED EMBOLIZATION. CATHETER INTEGRITY IS VERIFIED BY ANGIOGRAPHICALLY CONFIRMING THAT CONTRAST AGENT IS EXITING ONLY FROM THE CATHETER TIP WHILE VIEWING THE ENTIRE DISTAL SECTION OF THE CATHETER.? RELATED MDRS FOR THIS EVENT: 2029214-2020-00168, 2029214-2020-00169. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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Patient 1
MEDTRONIC RECEIVED INFORMATION THAT ONE MARATHON CATHETER RUPTURED DURING ONYX INJECTION. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A DURAL ARTERIOVENOUS FISTULA (DAVF). THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. THE MARATHON MICROCATHETER WAS DELIVERED TO THE TARGET SITE, WASH WAS PERFORMED, AFTER 0.23CC OF DMSO WAS INJECTED, WHEN AN ATTEMPT WAS MADE TO INJECT ONYX. IT WAS REPORTED THAT SINCE IT WAS A RELATIVELY SAFE POSITION, AFTER PUSHING IT WITH A LITTLE MORE FORCE, THE RUPTURE OCCURRED AT THE PINHOLE AT DISTAL REGION ABOUT 4 CM, SO THE CATHETER WAS IMMEDIATELY REMOVED. THE CATHETER WAS DISCARDED. THE REMAINING VIAL OF THE FIRST ONYX WAS RETRIEVED. AFTER THAT, ANOTHER CATHETER (MARATHON) WAS USED. ANOTHER CATHETER WAS USED, AND THE PROCEDURE WAS CONTINUED. THE TARGET SITE WAS ALMOST OCCLUDED. THERE WAS NOT ANY PATIENT INJURY REPORTED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS PER THE IFU. THE DELIVERY CATHETER CAVITY FILLED WITH DMSO. THE INFUSION RATE AS RECOMMENDED PER THE IFU AND ONYX INJECTION TOOK 2 SECONDS.