Model Number EP003994S |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 an ablation procedure while the physician was preparing the transseptal needle by inserting into a competitor sheath, the needle tore the dilator of the sheath.The sheath and needle were replaced and the issue repeated.The physician was able to complete the puncture with the second needle.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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The full needle was returned, analysis was performed and no anomalies were found.A good faith effort will be made to obtain the applicable information relevant to the report.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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Search Alerts/Recalls
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