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Model Number TPW32 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Product lot number? did the operating surgeon observe any suture deficiency or anomaly before or during the placement? what was happening when the suture/wire breakage occurred? please specify.Was any medical or surgical intervention required due to the suture/wire post op breakage? the procedure was stated to be cabgx3.What is mean by the ¿x3¿? are any actual or representative(unopened) samples being returned?.
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Event Description
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It was reported that the patient underwent a cabgx3 on (b)(6) 2021 and a temporary pacing wire was used.Post-op on (b)(6) 2021, a wire fractured.The epicardial wire broke at the point where wire connects to post.The wire had been in use at time of breakage but resulted in no harm to patient.There were no adverse patient consequences.Additional information has been requested.
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Search Alerts/Recalls
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