Model Number IPN000255 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2021 |
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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It was reported that the intra-aortic balloon (iab) catheter was noted kink during procedure.The iab was unable to be inserted.As a result, the hospital staff open up a new iab catheter and the procedure was successful.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4) the product was not returned for investigation.The reported complaint that the "intra-aortic balloon (iab) catheter was noted kink during procedure" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the intra-aortic balloon (iab) catheter was noted kink during procedure.The iab was unable to be inserted.As a result, the hospital staff open up a new iab catheter and the procedure was successful.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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