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Catalog Number UNK-CV-DAN-DXT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Embolism (1829); Occlusion (1984); Vascular Dissection (3160)
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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A post market clinical follow-up (pmcf) survey was conducted on behalf of medtronic to seek out potential new risks and assess performance of the dxterity diagnostic catheter.Survey results were obtained from an vascular surgeon in practice 16 years.In the past 12 months the physician performed 50 procedures using the dxterity diagnostic catheter.30 procedures using the 5 fr x 100cm, 10 procedures using the intermediate sizes, and 10 procedures using the 6f x 125cm.The following complications adverse events/effects were encountered when using the dxterity diagnostic catheter product over the last 12 months.4 dissection events occurred which were related to a pre-existing condition or comorbidity.1 plaque dislodgement event occurred which was related to a pre-existing condition or comorbidity.1 embolization event occurred which was related to a pre-existing condition or comorbidity.1 vascular occlusion event occurred which was related to a pre-existing condition or comorbidity.
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Search Alerts/Recalls
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