This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a planned therapeutic coronary procedure, inside the body, while passing through the lesion, the image of the manufacture's device disappeared.There is no patient injury.Calcification: none.The returned device was visually and microscopically inspected and damage was observed.It could not be concluded whether a small portion of the adhesive from the proximal fillet was missing.It could not be conclusively determined how and when the cause of the observed damage occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted in an abundance of caution as it could not be conclusively determined no adhesive was missing from the manufacture's device.There is a potential for harm if the malfunction were to recur.
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This case was reviewed and investigated according to the manufacturer''s policy.Internal reference: (b)(4).This follow-up supplemental report #1 is being submitted to report additional investigation findings, to wit: there is no potential for harm if the malfunction were to recur.This complaint was reassessed based on an engineering study that indicated, this family of catheters do not exhibit any adhesive detachment during normal use.There is no evidence of abnormal use conditions, it is likely the adhesive detached post-procedure, during the process of returning the device for analysis.There was no patient injury, no status decline, no adverse event, and no unplanned additional medical or surgical intervention reported.There is no potential for harm if the malfunction were to recur.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
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