A2): patient''s date of birth, age unk a3): patient''s gender unk a4): patient''s weight unk a5a./5b.): patient''s ethnicity/race unk b6): relevant tests/laboratory data unk b7): other relevant history unk h3): the turbo-elite and separated marker band were returned for evaluation.Visual inspection of where the marker band should be, found epoxy exposed on the distal tip with no locking feature present.Just proximal to the missing locking feature, there was inadequate epoxy.No damage was observed on the marker band.During functional testing, it was confirmed that dimensions of the locking feature, and the inner and outer diameters of the marker band, conformed to the specified drawings.H6): based on device evaluation and investigation, the cause of the marker band detachment could not be established.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 an alleged death or deterioration in the state of the health of any person.
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A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the mid popliteal region.A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.Three passes were made through the popliteal region successfully.Then, one pass was attempted in a tibial artery when the turbo-elite could not be advanced within the vasculature.During removal, it was observed that the distal marker band had detached within the patient.A balloon was used to retrieve the marker band, and a balloon angioplasty was performed to complete the case.The patient survived the procedure.This event captures the turbo elite distal marker band which separated, requiring intervention for retrieval.
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