EDWARDS LIFESCIENCES RETROGRADE CORONARY SINUS CARDIOPLEGIA CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number RC2012 |
Device Problems
Inflation Problem (1310); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problems
Hemorrhage/Bleeding (1888); Hemorrhage/Bleeding (1888); Cardiac Perforation (2513); Vascular Dissection (3160)
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Event Date 10/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Vascular perforations may occur with the use of several of our devices.A perforation is typically the result of excessive force combined with challenging anatomy and not a malfunction of the device.In this case, it was reported that there was tearing of the coronary sinus (cs) during use with the rc2012.The balloon inflated eccentrically with a globular shape on the side of the balloon while inflating.The root cause cannot be conclusively determined with the available information.It is unknown whether patient and/or procedural related factors may have contributed to the event.The subject device has not been returned for evaluation.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If any new information is received, a supplemental report will be submitted accordingly.
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Event Description
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It was reported that during use of the retrograde device, bleeding was observed due a torn coronary sinus.As reported, the balloon inflated eccentrically.A globular shape was confirmed on a side of the balloon while inflating.The lateral diameter of the balloon got wider than normal.Another device was used.No additional information was provided.
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Manufacturer Narrative
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Customer report that "balloon inflated eccentrically" was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, a cardioplegia balloon aneurysm was observed.The cardioplegia balloon inflated without leakage, but an aneurysm formed from a weakened wall of the balloon.All through lumens were patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Unfortunately, the root cause of this event cannot be determined at this time.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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