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

Catalog Number NA-3437

Device Problem Particulates (1451)

Patient Problem Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  malfunction  

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 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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: njemile crawley ; 14401 w. 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8072235
• MDR Text Key: 128401461
• Report Number: 1718850-2018-00020
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622104374
• UDI-Public: 00803622104374
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K943934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: NA-3437
• Device Lot Number: 1800900038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1