MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND AORTIC ARCH CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	RT-xxxxx
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Excessive Tear Production (2235)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up communication with the customer, livanova learned that the device was not saved for return and was inadvertently discarded due to the distressed situation.The customer reported that there did not appear to be anything physically wrong with the device that might have caused the tear.The surgeon was able to repair the damaged ivc without additional harm to the patient.The surgeon was reportedly unsure how the tear could have occurred and suggested that it may have become stuck on the ivc somehow.At this time, it is unclear whether or not there was a malfunction of the device or if the cannula contributed to the patient injury in any way.At this time, not other similar events have been reported against this catalog or lot number.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by customer.
Event or Problem Description
Livanova received a report that the pericardium filled with dark blood and a tear was noticed in the inferior vena cave following decannulation of the aortic arch cannula during a procedure.The patient reportedly lost 250ml of blood and required a primary surgical repair of the tear.On march 26, 2018, livanova received a user medwatch report (mw5075826) related to this issue.

• Brand Name: AORTIC ARCH CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 7399677
• Report Number: 1718850-2018-00008
• Device Sequence Number: 19200177
• Product Code: DWF
• UDI-Device Identifier: 00803622105500
• UDI-Public: (01)00803622105500(240)RTS-13029(17)201130(10)1731700077
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K943934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: RT-xxxxx
• Device Catalogue Number: RTS-13029
• Device Lot Number: 1731700077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other