Catalog Number 0684-00-0549-02 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hemorrhage/Bleeding (1888); Aortic Dissection (2491)
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Event Date 09/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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The customer indicated that the device is not returning to the manufacturer and we're unable to complete an evaluation on the affected product.If additional information is provided or the product becomes available a supplemental report with our additional findings will be provided.(b)(4).
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Event Description
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The iab catheter was inserted in a patient with ami, the surgeon was unable to pass through the sheath and pushed harder causing aortal dissection.Compression applied for 90 minutes which stopped the bleeding.Intra-aortic balloon therapy was discontinued.
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Manufacturer Narrative
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Date was inadvertently not entered in the initial mdr.Date: (b)(6) 2016.
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Event Description
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The iab catheter was inserted in a patient with ami, the surgeon was unable to pass through the sheath and pushed hardercausing aortal dissection.Compression applied for 90 minutes which stopped the bleeding.Intra-aortic balloon therapy was discontinued.
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Search Alerts/Recalls
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