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 08/12/2021 |
Event Type
Injury
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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) ruptured.It was noted that a high-pressure alarm occurred, and blood was in the gas tubing.As a result, the iab was removed without difficulty and a second iab was inserted at a different insertion site.There was no report of patient complications 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 the intra-aortic balloon (iab) ruptured.It was noted that a high-pressure alarm occurred, and blood was in the gas tubing.As a result, the iab was removed without difficulty and a second iab was inserted at a different insertion site.There was no report of patient complications or death.
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Search Alerts/Recalls
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