ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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Model Number IPN000254 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/31/2020 |
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) ruptured during use on a patient.As a result, the iab was removed from the patient.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that the intra-aortic balloon (iab) ruptured during use on a patient.As a result, the iab was removed from the patient.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of iab leak suspected is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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