Model Number G34111 |
Device Problems
Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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As reported to customer relations, "the stent got stuck in the clear sheath.They physician noticed a kink in the clear sheath.Physician indicated this could have been from a stricture or user error on their part.A second stent (lot# c1601025) was opened, and she again had a difficult time getting the stent thru the clear sheath.Both stent were ultimately placed." note: the physician cut the clear outer sheath due to the metallic stent being stuck.The physician did not want to lose access and she needed to get a wire in.
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Manufacturer Narrative
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This report is being submitted as a cancellation report.Initial assessment erred on the side of caution pending investigation.Following the lab evaluation of the device it has been confirmed that the clear sheath was had a slight kink.No adverse effects to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Reference: (b)(4) rev.010 section: 3.3.2 "kinks".Overall risk assessed as category iia (low).No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.
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Event Description
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As reported to customer relations, "the stent got stuck in the clear sheath.They physician noticed a kink in the clear sheath.Physician indicated this could have been from a stricture or user error on their part.A second stent (lot#: c1601025) was opened, and she again had a difficult time getting the stent thru the clear sheath.Both stent were ultimately placed." note: the physician cut the clear outer sheath due to the metallic stent being stuck.The physician did not want to lose access and she needed to get a wire in.
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Search Alerts/Recalls
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