Model Number HGK0008-70 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Blood Loss (2597)
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Event Date 08/31/2016 |
Event Type
Injury
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Manufacturer Narrative
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A review of the complaint 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, the outcome of the investigation would tend to indicate that the product was not defective at the time of manufacturing.
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Event Description
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During an iliofemoral bypass procedure performed on (b)(6) 2016, there was a lot of bleeding through the graft walls (more than "blush") when the clamp was removed.The surgeon had to manually coagulate the graft with the patient blood to control the bleeding, and worked the clamp open and closed to help to coagulate as well.The graft remained implanted and the patient was reported as being fine.
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Manufacturer Narrative
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(b)(4).Two remaining fragments of the complaint device were sent to an outside laboratory for macroscopic and scanning electron microscopy (sem) evaluation.The objective of the study was to evaluate the presence of any structural abnormality visible on the external side of the returned fragments and to evaluate the presence of collagen material.The sem analysis pointed out focal infiltration of collagen material.No significant abnormality such as large tear, loss of textile cohesion, holes and signs of cut were observed.The sem analysis corroborated the macroscopic analysis.(b)(4).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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Search Alerts/Recalls
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