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

Catalog Number	NA-3437
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Nerve Proximity Nos (Not Otherwise Specified) (2647)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date was not provided.This information will be provided in a supplemental report if made available.At this time, the root cause of the particle/substance exiting the device is unknown.As the product is opened and undergoes re-processing and re-sterilization at the distributor before reaching the customer, it is unknown if the particle/substance was introduced during manufacturing or re-processing at the distributor.At this time, the impact of this event is unknown, as the identity of the substance/particle has not been determined.There are numerous potential sources of the black material, and no device has been made available for return so an investigation has not been performed.No patient injury was reported by the hospital.Though the involved cannula was not made available for return, product with the same catalog number and an unknown lot has been recently returned for a different complaint from the same distributor.The tips of these returned cannulae were analyzed and found to be conforming to expectations.Cosmetic discoloration was observed on the device tips, however this is a known result of the tip-forming process and poses no patient risk.Darker areas observed on some of the returned cannula tips were not found to transfer with alcohol wipes and no embedded or loose particulate was identified.Ftir analysis performed on the tubing confirmed that there was no foreign material on the tips.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available for return.
Event or Problem Description
Livanova received a report that something black came out of the aortic arch cannula during a procedure.There was no report of patient injury.

• Brand Name: AORTIC ARCH CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 8072235
• Report Number: 1718850-2018-00020
• Device Sequence Number: 2280403
• Product Code: DWF
• UDI-Device Identifier: 00803622104374
• UDI-Public: 00803622104374
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: NA-3437
• Device Lot Number: 1800900038
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1