Model Number 9-ASD-MF-025 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported a 25mm amplatzer cribriform occluder was chosen for implant.During procedure, while positioning the device, the left disc deployed with a deformation and was removed from the patient.The device was tested while outside the patient and the device continued to present with a deformation.A new, 25 mm amplatzer cribriform occluder was used to complete the procedure.There were no consequences to the patient.No additional information had been provided.
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Manufacturer Narrative
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The reported event of device deformity could not be confirmed.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.Please note, per the instructions for use, artmt600034247 revision b "contraindications: treatment of patients with patent foramen ovale (pfo) defects.This device has not been studied in patients with pfo defects.".
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Search Alerts/Recalls
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