Catalog Number CV-17702-E |
Device Problems
Difficult to Insert (1316); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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The customer reports: "technical difficulty of passage due to distortion of the guide wire, it bent at the entrance of the skin.Successful passage in the 4th attempt in femoral access".Another device was inserted.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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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Event Description
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The customer reports: "technical difficulty of passage due to distortion of the guide wire, it bent at the entrance of the skin.Succcessful passage in the 4th attempt in femoral access".Another device was inserted.
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Search Alerts/Recalls
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