Model Number C315HIS02 |
Device Problem
Accessory Incompatible (1004)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary: the delivery catheter was returned and analyzed.Analysis indicated that the mechanical operation of the catheter slitting showed a spiral slit.The mechanical operation of the catheter shaft was kinked.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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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, there was slitting difficulty between the slitter and the delivery catheter.It was noted the lead dislodged twice during slitting two different catheters and an anomaly with the slitter was suspected.A third catheter was utilized and the lead was implanted.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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