Model Number 9-ATV09F45/80 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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Related manufacturer reference number: 2135147-2020-00394.On (b)(6) 2020, an 18mm amplatzer septal occluder was implanted using a 9f amplatzer trevisio delivery system.On (b)(6) 2020, the occluder was explanted due to device embolization.The physician reported that the "pushability with the trevisio cable is insufficient to do a complete wiggle test and.This is the origin of migration of device." the patient status was reported to be stable and discharged.
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Manufacturer Narrative
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An event of inadequate pushability with the treviso cable was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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