Catalog Number 1012450-12 |
Device Problems
Detachment Of Device Component (1104); Difficult To Position (1467)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the patient underwent a procedure to treat bifurcation lesions in the left anterior descending (lad) artery and the diagonal artery.One nc trek dilatation catheter had been advanced through the guide catheter and placed in the diagonal artery.The 3.25 x 12 mm nc trek dilatation catheter was advanced through the guide catheter, with the first nc trek also; however, resistance was felt with the guide catheter and the dilatation catheter.Force was applied and the proximal shaft of the 3.25 x 12 mm nc trek separated inside the guide catheter.The separated segments of the nc trek were removed using a hemostat.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Visual and dimensional inspection was performed on the returned device.The shaft separation was confirmed.The difficulty positioning the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.The investigation determined the reported difficulty positioning the guiding catheter and balloon catheter appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Search Alerts/Recalls
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