Catalog Number AK-45703-PB1A |
Device Problems
Break (1069); Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It is reported that the physicians are pulling swg against the bevel of the needle when in the patient to re-adjust.Physician(s) informed that this manipulation is against ifu.
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Event Description
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The customer reports: the physicians complained about kinking/shearing when they were manipulating it (swg) inside the needle and pulling back against the bevel of the needle.The users have been using different size insertion needle and swg (spring wire guide) combinations.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire."
based on the report that the customer withdrew the guide wire against the needle bevel, it was determined that user error caused or contributed to this event.An in-service has been initiated for this issue.
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Event Description
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The customer reports: the physicians complained about kinking/shearing when they were manipulating it(swg)inside the needle and pulling back against the bevel of the needle.The users have been using different size insertion needle and swg (spring wire guide) combinations.
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Search Alerts/Recalls
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