Catalog Number CDC-45703-P1A |
Device Problems
Unraveled Material (1664); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports: the doctor attempted placement and the guidewire was difficult to pass.Tip was validated using ultrasound.The doctor was unable to get catheter to pass.The distal portion of the wire began to coil.The entire wire and catheter were removed.A new kit was used.Insertion and passage was completed without complications.
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Event Description
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The customer reports: the doctor attempted placement and the guidewire was difficult to pass.Tip was validated using ultrasound.The doctor was unable to get catheter to pass.The distal portion of the wire began to coil.The entire wire and catheter were removed.A new kit was used.Insertion and passage was completed without complications.
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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 based upon a lot number from the sales history data 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.
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Search Alerts/Recalls
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