Model Number 901068-16 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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The shepard wire was advanced through a 018 navicross catheter but became stuck and could not be advanced through.When removing the shepard wire, the wire coating was damaged and peeled off.No components were left in vivo.A second shepard wire was used and was successfully advanced to the superficial femoral artery (sfa).When removing the second shepard wire, it became stuck inside the navicross catheter.Both were removed together.A new navicross catheter and a asahi guide wire were used to complete the procedure.The patient was stable and did not experience any impact from the reported issues.
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Manufacturer Narrative
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Complaint investigation underway and will be attached to this report.
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Manufacturer Narrative
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Complaint investigation is attached to this report.
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Event Description
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The shepard wire was advanced through a 018 navicross catheter but became stuck and could not be advanced through.When removing the shepard wire, the wire coating was damaged and peeled off.No components were left in vivo.A second shepard wire was used and was successfully advanced to the superficial femoral artery (sfa).When removing the second shepard wire, it became stuck inside the navicross catheter.Both were removed together.A new navicross catheter and a asahi guide wire were used to complete the procedure.The patient was stable and did not experience any impact from the reported issues.
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Search Alerts/Recalls
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