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Model Number N/A |
Device Problems
Difficult to Remove (1528); Stretched (1601); Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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G4: pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional, relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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It was reported that the wire guide from a neff percutaneous access set unraveled during a percutaneous transhepatic biliary drainage procedure.After successful puncture with the access needle, bile flow was observed.Then the wire was introduced into the bile duct.After reaching the bile duct, it was found that the wire guide could not be withdrawn through the needle.Upon removal, it was discovered that the front end of the wire guide elongated and unraveled.Use of the wire was immediately discontinued.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Search Alerts/Recalls
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