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Model Number IPN000263 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2021 |
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 when the patient underwent pci with an intra-aortic balloon catheter (iabc), the catheter worked normally but did not show aortic pressure.It was noted that the doctor found no return of blood.As a result, a new catheter was used, and the operation proceeded normally.There was no report of patient complications, serious injury, or death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of iab central lumen occluded is confirmed.During the investigation, the catheter central lumen aspiration/flushing test was initially unsuccessful.A kink was noted to the central lumen and a blood clot was cleared from the central lumen during the guidewire test.The blood built up in the central lumen may have resulted from not maintaining the patency of the arterial line.A blood clot or kink to the central lumen can lead to occlusion and are potential causes of the reported complaint.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 when the patient underwent pci with an intra-aortic balloon catheter (iabc), the catheter worked normally but did not show aortic pressure.It was noted that the doctor found no return of blood.As a result, a new catheter was used, and the operation proceeded normally.There was no report of patient complications, serious injury, or death.
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Search Alerts/Recalls
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