Catalog Number CDC-45703-1A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Tachycardia (2095)
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Event Date 12/07/2020 |
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 complaint is reported as: physician complained of "very flimsy guidewire" in kit "causing patient to go into vtach".Additional information was requested, but not received at the time of this report.
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Event Description
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The complaint is reported as: physician complained of "very flimsy guidewire" in kit "causing patient to go into vtach".Additional information was requested, but not received at the time of this report.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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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