The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that a hole was noted on the catheter shaft distal end.During the functioning test, it was found that resistance noted when advancing the mandrel through the lumen due to the damage at the distal end.And procedural fluid was expelled from the catheter during flush.Per additional information received, no anomalies were noted to the device prior to use.The anatomy was noted to be severely tortuous which is likely to have contributed to the reported event.The hole noted in the microcatheter during analysis is likely to have been caused during the attempt to push the coil out of the microcatheter with the guidewire.The communication log indicates intermittent flush was used which is consistent with the blood noted in the microcatheter during analysis.As per the dfu "caution: in order to achieve optimal performance of stryker neurovascular microcatheters and to maintain the lubricity of the hydrolene® coating surface, it is critical that a continuous flow of appropriate flush solution be maintained between the stryker neurovascular microcatheter and guide catheter, and the microcatheter and any intraluminal device.In addition, flushing aids in preventing contrast crystal formation and/or clotting on both the intraluminal device and inside the guide catheter and/or the microcatheter lumen".Therefore an assignable cause of use error caused or contributed to event will be assigned to the 'catheter shaft has hole/perforation' and 'catheter friction'.As the investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
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