The pipeline braid was returned for evaluation without the pipeline flex pushwire.The reason the pipeline flex pushwire was not returned for evaluation was not provided.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline braid was observed to be fully open with both ends having slight fraying.Dried blood was found throughout the pipeline braid.No other anomalies were observed.The product analysis does not suggest a potential or confirmed manufacturing issue; therefore, no lot history record review is required.This device was used to treat an aneurysm.However, the treatment site for this device is unknown as the treatment site was not reported.Additionally, the patient anatomy condition was not reported; therefore any contributing factors from the patient anatomy could not be assessed.Based on the analysis findings and the reported event details, the customer¿s report was not confirmed.The cause for the reported e xperience could not be determined as the returned pipeline braid was observed to be fully open with damage on both ends (fraying).It is possible the damaged braid may have contributed to the reported issue.However, the causer for the damage could not be determined.No evidence was found to suggest that the device failed to meet specifications; therefore manufacturing has been ruled out as a potential cause.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu): the user should "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.¿.
|