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Model Number LVZRMS180J |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/16/2018 |
Event Type
malfunction
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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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It was reported that during the implant procedure, the guidewire unraveled when being removed from the left ventricular lead after it was placed into vein.The physician cut the wire at the proximal end of the lead, removed the lead and was able to extract the remaining portion of the wire from inside the lead.The lead was evaluated and determined to be undamaged and was re-implanted using a different guidewire.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the guidewire was returned in segments, and analyzed.Analysis indicated that the guidewire was unraveled.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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