Model Number RC2014 |
Device Problem
Material Rupture (1546)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Event Description
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It was reported a rc2014 burst in the patient and created a hole in the heart.Per the perfusionist, the retrograde cannula was either frozen or burned during a maze procedure.Perfusionist notified physician of high-pressure with low flow (less than 30cc/min) while delivering retrograde cardioplegia into coronary sinus with the tip frozen/burnt caused occlusion of tip of the cannular which caused the catheter to rupture.The patient required a bovine pericardial patch to repair damage cause by the cannula rupturing.It is unknown now long the cannula was in place at time of rupture.No aseptic solution or cleaning agent was used on the device.There was no manipulation of the cannula when the leak occurred.
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Manufacturer Narrative
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H6- conclusion code- cause traced to another device.The device was not returned for evaluation, however one color image was provided showing the tips of two used devices.The reported damage and occlusion is unable to be confirmed via evaluation of the image.Based on the provided information, the most likely cause of the reported burst is damage caused by another device.
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Event Description
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It was reported a rc2014 burst in the patient and created a hole in the heart.Per the perfusionist, the retrograde cannula was either frozen or burned during a maze procedure.Perfusionist notified physician of high-pressure with low flow (less than 30cc/min) while delivering retrograde cardioplegia into coronary sinus with the tip frozen/burnt caused occlusion of tip of the cannular which caused the catheter to rupture.The patient required a bovine pericardial patch to repair damage to the organ caused by the cannula rupturing.The patient was discharged from hospital.
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Manufacturer Narrative
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Added information to a2, a3, b5.
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Search Alerts/Recalls
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