Catalog Number 12673-05 |
Device Problems
Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.Investigation is not yet complete.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The other two perclose proglide devices are filed under separate medwatch manufacturer report reference number.
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Event Description
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It was reported that suture placement in the right common femoral artery was attempted with a proglide device using the pre-close technique via a 12f sheath.Reportedly, the proglide suture came out with the plunger.The sutures of two new proglide devices were successfully pre-placed.The stent-graft procedure was completed.The pre-placed sutures were tightened; however, hemostasis was not completed successfully.Manual arterial compression was used to achieve hemostasis.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Subsequent to the initial medwatch report, the following additional information was received: the two pre-placed proglide sutures could achieve hemostasis.No issue was found with the two additional proglide devices.A risk assessment review was not conducted as there was no device malfunction or adverse patient effect.However, because the initial medwatch report has already been filed, this event must remain reportable.No investigation required.
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Event Description
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Subsequent to the initial medwatch report the following additional information was received.Reportedly, the two pre-placed proglide sutures were successfully placed and could achieve hemostasis.No device issue was being reported with the two additional proglide devices.No additional information was provided.
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Search Alerts/Recalls
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