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 06/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: see mdr# 3010532612-2020-00180 ((b)(4)), mdr# 3010532612-2020-00177 ((b)(4)), mdr# 3010532612-2020-00178 ((b)(4)), mdr# 3010532612-2020-00179 ((b)(4)) as the reports are related to the same patient.
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Event Description
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It was reported that the intra-aortic balloon (iab) was used on the patient and was noted that the balloon ruptured in patient during cpr.As a result, a new iab was used, using the same insertion site.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No part 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.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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00180 (b)(4), mdr# 3010532612-2020-00177 (b)(4), mdr# 3010532612-2020-00178 (b)(4), mdr# 3010532612-2020-00179 (b)(4) as the reports are related to the same patient.
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Event Description
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It was reported that the intra-aortic balloon (iab) was used on the patient and was noted that the balloon ruptured in patient during cpr.As a result, a new iab was used, using the same insertion site.There was no report of patient complications, serious injury or death.
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