ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
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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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(b)(4).
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Event Description
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It was reported that blood was seen in the intra-aortic balloon (iab) catheter, which could indicate a breakdown in balloon integrity.Additional information was received that therapy was discontinued soon after the helium leak alarm could not be resolved.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn #(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the catheter which allowed blood to enter the helium pathway.The root cause of the broken fiber 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 blood was seen in the intra-aortic balloon (iab) catheter, which could indicate a breakdown in balloon integrity.Additional information was received that therapy was discontinued soon after the helium leak alarm could not be resolved.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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