MAUDE Adverse Event Report: LIVANOVA USA, INC. CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	SU-XXXXX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).During follow-up communication with the customer, the user stated that the device tip was placed through a port and must have fallen off when it was pulled back through the chest wall.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 tip of an rigid tip suction wand used during a minimally-invasive valve repair procedure on (b)(6), 2018 was retained in the patient's chest in the right pleural cavity, confirmed by x-ray, after the procedure.The patient underwent an additional surgery on (b)(6) 2018 to remove the device.The tip was removed without complication via the existing incision.The tip was discarded.
Additional Manufacturer Narrative
The complained cannula was not made available for investigation.The customer provides a picture showing the detachment of the tip from the body of the cannula.The issue is confirmed based on this evidence.No unit of the same lot of the complained cannula was available in livanova usa warehouse.A pull test, performed on units pulled from the stock, confirmed the boding of the tip with the body of the cannula is in compliance with product specifications.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the unit was not available for investigation, no specific root cause of the issue could be identified.Basing on follow up information with the customer, it cannot be excluded that the detachment of the tip was triggered by incorrect handling of the cannula during the procedure.According to livanova complaint database, this is no other similar event over the last year.Livanova usa will keep monitoring the market.Device not available.

• Brand Name: CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
• 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: 8029864
• Report Number: 1718850-2018-00019
• Device Sequence Number: 19228671
• Product Code: DWF
• UDI-Device Identifier: 00803622105913
• UDI-Public: (01)00803622105913(240)SU-29602(17)190531(10)1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K982891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 05/31/2019
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-29602
• Device Lot Number: 1613800089
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 03/27/2019
• 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: Hospitalization; Life Threatening; Other; Required Intervention