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Model Number IPN923527 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that "the guidewire (extra stiff gw, 0.035inch, cook medical japan) did not come out from the tip of the catheter during use.Therefore, a new kit was used instead to complete the procedure.There was no report of patient complications, serious injury or death.".
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that "the guidewire (extra stiff gw, 0.035inch, cook medical japan) did not come out from the tip of the catheter during use.Therefore, a new kit was used instead to complete the procedure.There was no report of patient complications, serious injury or death.".
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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.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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