Model Number 9-PDA2-04-06 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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Further information regarding this event has been requested.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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On (b)(6) 2019, a 4/6mm amplatzer duct occluder ii and a 6mm amplatzer muscular vsd occluder were selected to close an aortic to right ventricular fistula.While attempting to deploy both devices, the physician reported that both devices were unstable.The case was aborted due to difficulty closing the defect.Additional information has been requested.
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Manufacturer Narrative
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An event of "attempting to deploy the device but the device was unstable" was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported incident could not be conclusively determined.Please note per the instructions for use, document (b)(4) rev e , "the amplatzer¿ duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus.".
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Event Description
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On (b)(6) 2019, a 4/6mm amplatzer duct occluder ii and a 6mm amplatzer muscular vsd occluder were selected to close an aortic to right ventricular fistula.While attempting to deploy both devices, the physician reported that both devices were unstable.The case was aborted due to difficulty closing the defect.Since no additional information has been provided, we will proceed with closure.If additional information becomes available, the file will be reopened.
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Search Alerts/Recalls
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