Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.A video of the angiographic material which was recorded with a mobile was reviewed.The actual complaint event is not visible.Review of the video provided did not lead to any further information regarding the nature of the complaint.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all inprocess and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the reported event is most likely related to the handling during the procedure (i.E.Insufficient deflation time).It should be noted that the ifu clearly states that the instrument shall be deflated for at least 35 seconds.
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