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Model Number IPN000263 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that the guide wire cannot pass through the central lumen of the intra-aortic balloon (iab) when the iab was implanted.As a result, the iab was removed and a new iab was used.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 of iab tight over guide wire 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 guide wire cannot pass through the central lumen of the intra-aortic balloon (iab) when the iab was implanted.As a result, the iab was removed and a new iab was used.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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