Catalog Number D128211 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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We are working on the device history record (dhr), once we get more information it will be submitted in the supplemental.(b)(4).
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Event Description
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It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a pentaray nav high-density mapping eco catheter and during the procedure the wire was exposed on the deflection position.No adverse patient consequences were reported.
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Manufacturer Narrative
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Additional information was received on 8/11/2018 indicating the manufacture date: 1/10/2018 and expiration date: 1/09/2021.Corresponding fields of this report have been updated.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer ref no: (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a pentaray nav high-density mapping eco catheter and during the procedure the wire was exposed on the deflection position.No adverse patient consequences were reported.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.(b)(4).
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Search Alerts/Recalls
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