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Model Number 150075 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemoptysis (1887); Aortic Dissection (2491)
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Event Date 02/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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A 7f pulmonary artery wedge pressure catheter was used during a procedure.There was no damage on the catheter when it was removed.The balloon was inflated and the catheter was in good working condition.It is indicated that a dissection occurred in the distal left pulmonary artery, from the balloon on the catheter tip bobbing in and out of the pulmonary artery.This led to hemoptysis and intubation, and it was necessary to move the patient to another facility.The patient was stabilized, spent several days in a rehab facility and was discharged approx 8 days after the initial procedure.
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Manufacturer Narrative
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Cine image review: an image shows the complaint device in the pulmonary artery as reported by the account.The image is labelled with an a and a line that measures 7.3mm.It is possible that this measurement is for the reported dissection, though it is not possible to see the dissection in the image provided.A second contrast image was provided from a different orientation with labels a and b measuring 3.4mm and 7.4 mm respectively.It is possible that these measurements are for the dissection though it is not possible to see the dissection due to the labels.The guide wire and catheter are visible in the image.A third image was provided without contrast.The complaint device and guide wire are visible in the image and a label a corresponding to a measurement of 7.4mm.It is possible that this is the length of the dissection, though it is not possible to tell from the images provided.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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