Model Number 77420 |
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 04/24/2014 |
Event Type
malfunction
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Event Description
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Medtronic received information that during use of this arterial cannula in a bypass procedure, the surgeon observed a split in the outer lumen of the wirewound portion of the device near the double depth marker.The split did not go through the inner lumen of the cannula and there were no leaks observed.The perfusionist stated that the split may have been the result of a clamp issue.The cannula was not replaced and the procedure was successfully completed with no adverse patient effects.Product return is expected.
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Manufacturer Narrative
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The product has not yet been received by medtronic for analysis.After receipt and completion of analysis, a supplemental report will be filed.(b)(4).
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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 the narrower section of the cannula.The split was in the outer lumen of the device but did not continue through the inner lumen.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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Event Description
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Medtronic received information that during use of this arterial cannula in a bypass procedure, the surgeon observed a split in the outer lumen of the wirewound portion of the device near the double depth marker.The split did not appear to go through the inner lumen of the cannula and there were no leaks observed.The perfusionist stated that the split may have been the result of a clamp issue.The cannula was not replaced and the procedure was completed successfully with no adverse patient effects reported.The product was returned for analysis.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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