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Catalog Number ZNGRS180HJ |
Device Problems
Retraction Problem (1536); Material Distortion (2977)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/13/2017 |
Event Type
malfunction
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Event Description
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The physician was using a zinger wire when placing a medtronic lv lead.The lesion was non-calcified and non-tortuous, with no stenosis.The zinger wire was prepped per ifu.No resistance was noted when when advancing the wire in the vessel.No resistance was noted when loading the wire through the lead.No force was applied to the wire during advancement.No resistance was noted when removing the wire from the lead but the wire came out stretched like a thread, and the radio-opaque part of the wire remained in the lead.The entire lead was taken out.A new wire was used to complete the procedure.No patient injury is reported.
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Manufacturer Narrative
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Product analysis summary: guide wire as received is coil wrapped, stretched and the core wire is broken.Distal tip and bond joint attached by coil wire.The broken end of core wire measures 1.5mm on the proximal side of the distal bond joint.Proximal bond to the end of the broken core wire, measures approx.27cm indicating that there are no missing components or material.Distal end of wire is stretched from the proximal bond forward.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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