Catalog Number SI-09875-A |
Device Problems
Failure to Advance (2524); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2021 |
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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It was reported the sheath was inserted for a planned cardiothoracic surgery.The anesthetist attempted to pass a swan ganz catheter through the sheath and was unable to pass it easily.It was extremely tight and once the protector cover was applied, even more difficult to move the swan further into the sheath.There was no harm to the patient.
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Event Description
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It was reported the sheath was inserted for a planned cardiothoracic surgery.The anesthetist attempted to pass a swan ganz catheter through the sheath and was unable to pass it easily.It was extremely tight and once the protector cover was applied, even more difficult to move the swan further into the sheath.There was no harm to the patient.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed on two lot numbers based on the sales history of the customer.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Search Alerts/Recalls
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