Model Number 9-ASD-024 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/18/2018 |
Event Type
Injury
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Event Description
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On (b)(6) 2018, a 26 mm amplatzer atrial septal occluder (aso) was selected to close an atrial septal defect with a pediatric patient.The 26 mm amplatzer aso was found to be too large so a 24 mm amplatzer aso was implanted.There was concern for the 24 mm amplatzer aso device on whether or not it was seated well and could cause possible erosion.On (b)(6) 2018, the patient went to the operating room (or) to have the device surgically removed and defect closed.The surgery was successful and the patient is reported as stable.The physician states that the 24 mm amplatzer aso device was removed due to the concern of the size of the device required to close the defect in relation to the small size of the patient.
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Manufacturer Narrative
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Event description: additional information was requested, but not provided by the physician or hospital.An event of user concern regarding the device being seated well was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.The physician stated that the concern was regarding "the size of the device required to close the defect in relation to the small size of the patient.".
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Event Description
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On (b)(6) 2018, a 26mm amplatzer atrial septal occluder (aso) was selected to close an atrial septal defect with a pediatric patient.The 26mm amplatzer aso was found to be too large so a 24mm amplatzer aso was implanted.There was concern for the 24mm amplatzer aso device on whether or not it was seated well and could cause possible erosion.On (b)(6) 2018, the patient went to the or to have the device surgically removed and defect closed.The surgery was successful and the patient is reported as stable.The physician states that the 24mm amplatzer aso device was removed due to the concern of the size of the device required to close the defect in relation to the small size of the patient.Operation reports were requested, but not provided by the physician or hospital.
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Search Alerts/Recalls
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