PERFUSION SYSTEMS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number 77422 |
Device Problem
Cut In Material (2454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/05/2014 |
Event Type
malfunction
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Event Description
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Medtronic received information indicating that after the completion of the bypass procedure, as this arterial cannula was removed, two splits were observed in the body of the cannula outside the patient's aorta.The cannula did not leak from the break sites and the inner lumen held in both locations.There was no consequence or serious injury to the patient.The product was returned to medtronic for analysis.
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Event Description
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Medtronic received information indicating that after the completion of the bypass procedure, as this arterial cannula was removed, a split was observed in the body of the cannula outside the aorta.The cannula did not leak from the break site and the inner lumen held.There was no consequence or serious injury to the patient.The product was returned to medtronic for analysis.
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Manufacturer Narrative
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Upon receipt at medtronic's quality laboratory, visual inspection confirmed that the cannula body had split in two different locations in the narrower section of the cannula.The splits were in the outer lumen of the device, exposing the wire winding, but did not continue through the inner lumen.The product was sent to the contract manufacturer for this cannula for additional examination and determination of root cause.(b)(4).
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Manufacturer Narrative
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The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Medtronic has initiated a formal investigation into recent events involving damage to the outer lumen of eopa arterial cannulae.At this time, there have not been any reports of damage to the inner lumen of any of the cannulae, any leaks, or any adverse patient effects as a result of these issues.(b)(4).
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