Model Number C315HIS02 |
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 03/27/2020 |
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 resistance was encountered when inserting the guidewire into the hemostasis valve of the delivery catheter.When forcibly inserted, the valve was found to be loose and the wire could not be inserted any further.A different catheter was used to complete the implant.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 delivery catheter was returned and analyzed.The hemostasis valve of the catheter was damaged.Visual analysis of the catheter 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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