Catalog Number AK-04550-S |
Device Problem
Material Too Rigid or Stiff (1544)
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Patient Problem
Tissue Damage (2104)
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Event Date 05/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports: physicians complain that the straight soft tip end of the guide-wire is not soft enough.In one instance, during line insertion into a radial artery the wire proved to be a hindrance the tip is too stiff and has caused a number of dissections as reported by physicians.Due to this the patient received radial artery damage.The patient condition is reported as fine and healing normal.
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Event Description
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The customer reports: physicians complain that the straight soft tip end of the guide-wire is not soft enough.In one instance, during line insertion into a radial artery the wire proved to be a hindrance the tip is too stiff and has caused a number of dissections as reported by physicians.Due to this the patient received radial artery damage.The patient condition is reported as fine and healing normal.
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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.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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