The investigation of the returned balloon protector was able to confirm it as the protector which is initially mounted to protect the balloon.Further two kinks were observed at its distal end, most probably as consequence of the removal.The provided angiographic images from the initial procedure have been reviewed and did not lead to any further information regarding the nature of the complaint.Review of the manufacturing history of the product detailed above did not reveal any non-conformity.The device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The event is related to known external factors, because the protector was not removed prior to insertion of the balloon.Please note that the instruction for use (ifu) states to: carefully remove the balloon protector by pulling on the very distal end of the protector.
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