Model Number IGK0010-40 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Blood Loss (2597)
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Event Date 07/19/2015 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation on-going.Additional information is being seeked.A follow-up will be sent upon conclusion of the investigation.
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Event Description
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During a vascular surgery performed on (b)(6) 2015, the graft was reported to bleed excessively, that required blood transfusion.Antifibrinolytic medication was administered.The event has been communicated to the designated complaint handling unit on october 08, 2015.
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Manufacturer Narrative
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A review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.
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Event Description
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The graft was removed and an other graft was used to complete the procedure.
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Search Alerts/Recalls
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