On (b)(6) 2020, a 20 mm amplatzer amulet occluder was selected for implant.On (b)(6) 2020, the patient became hospitalized and was monitored due to a hematoma and suspected pseudoaneurysm at the puncture site requiring no intervention.Imaging revealed there was no av-fistula.On (b)(6) 2020, the patient was discharged home.
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Additional information: d10, g4, h2, h3, h6 & h10.An event of hematoma and suspected aneurysm at the puncture site 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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