W. L. GORE & ASSOCIATES, INC. GORE CARDIOFORM ASD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER
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Model Number ASD37A |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Event Description
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Patient presented to the cardiac catheterization lab for an atrial septal defect repair.Surgeon opened and inserted a 30 mm and 32 mm gore® cardioform asd occluder, but was unable to safely deploy the devices in the defect.Both gore® cardioform asd occluder were removed.Surgeon decided to upsize to a 37 mm device.The staff opened the device and it was defective.The supplier provided us a reimbursement for the defective device.An additional 37 mm device was opened and inserted into the patient.The device was deployed and the procedure was completed without any complications.Due to the operational waste policy, 3 devices were opened and used as indented but ultimately 2 of the 3 devices were removed.The patient should be charged for all 3 devices per policy.
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Event Description
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Patient presented to the cardiac catheterization lab for an atrial septal defect repair.Surgeon opened and inserted a 30mm and 32mm gore® cardioform asd occluder, but was unable to safely deploy the devices in the defect.Both gore® cardioform asd occluder were removed.Surgeon decided to upsize to a 37mm device.The staff opened the device and it was defective.The supplier provided us a reimbursement for the defective device.An additional 37mm device was opened and inserted into the patient.The device was deployed and the procedure was completed without any complications.Due to the operational waste policy, 3 devices were opened and used as indented but ultimately 2 of the 3 devices were removed.The patient should be charged for all 3 devices per policy.
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