Model Number 0684-00-0480-07 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy on a coronary artery bypass graft (cabg) patient, the iab was damaged and the inner lumen was broken.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The product was not returned and so could not be evaluated.If provided we will send a supplemental report with our additional findings.A photo of the involved balloon was provided, where blood was visible on the membrane.Further visual examination of the provided photo revealed an inner lumen breakage inside the membrane.The evaluation confirmed the reported leak, which appeared to had been caused by a broken inner lumen, allowing inside the membrane.However, we were unable to conclusively determine how the breakage may have occurred since the device was not returned for evaluation.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy on a coronary artery bypass graft (cabg) patient, the iab was damaged and the inner lumen was broken.There was no patient harm or adverse event reported.
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Search Alerts/Recalls
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