According to the customer's response, the sample was not available for return and evaluation.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.However, multiple complaints were received regarding this issue, and capa (b)(4) was initiated to investigate the root cause of the radiopaque marker band detachment and correct it.
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During the procedure, under fluoroscopy, the doctor noticed that the radiopaque marker at the end of the introducer sheath was missing.The 2 markers on the dilator were visible, and the doctor was familiar with the option, that he noticed the 3rd marker on the end of the sheath was not there.The sheath was removed and another option filter was used.
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