The reported complaint indicated material deformation of zoom 71 and resistance during advancement.The zoom 71 catheter was returned for investigation.The investigation confirmed severe damage to the distal portions of the catheter shaft including stretching, kinking, and separation of the shaft material.The catheter returned for investigation was in two segments.The separation of the catheter is attributed to handling of the device after the procedure while it was being returned for investigation.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.Based on the complaint information provided and device investigation the most likely root cause is retraction of the zoom 71 through a kinked guide catheter.
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A patient was treated for an occlusion at the m1 segment.Access was obtained with a tracstar access catheter over a guidewire.The tracstar was positioned at the ica (internal carotid artery).A zoom 71 was then advanced through the tracstar.The patient's anatomy was reported to be tortuous.An abnormal interaction/resistance was noted between the catheters.The zoom 71 was advanced to the location of the kink, as observed under fluoroscopy, in the tracstar.Upon removal of the zoom 71 from the patient, the outer jacket was separated exposing the coil of the zoom 71 catheter.The coil was still holding both segments of the catheter together.The tracstar was removed from the patient and the kink was confirmed.A replacement tracstar and zoom 71 catheter were used to complete the procedure successfully.The patient achieved complete reperfusion with a tici 3 score.There was no intervention performed and no patient sequelae reported.
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