MAUDE Adverse Event Report: LIVANOVA USA, 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	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The involved device has been requested for return to livanova for further evaluation.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.
Event or Problem Description
Livanova received a report that a rigid tip suction wand was found to be missing the tip following cardiac surgery.The cardiac team searched for the tip in the chest of the patient and performed several diagnostic tests.The tip was unable to be located.There was no report of patient injury.
Additional Manufacturer Narrative
The complained su-12202 suction wand was returned to livanova usa inc for evaluation without the tip.According to standard manufacturing procedure, the tip is adhered to the suction wand with a cyano adhesive.Visual inspection of the returned wand found no residue or evidence of adhesive on the device.Livanova believes that the most likely cause of the failure is insufficient adhesive application by the operator during manufacturing.To prevent reoccurrence, manufacturing floor was retrained.Livanova will keep monitoring the market for similar issue.

• Brand Name: 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: 8108328
• Report Number: 1718850-2018-00022
• Device Sequence Number: 1900174
• Product Code: DWF
• UDI-Device Identifier: 00803622105814
• UDI-Public: (01)00803622105814(240)SU-12202(17)210731(10)1820600005
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K972503
• 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,Followup
• Report Date (Section B): 02/26/2019

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: 07/31/2021
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-12202
• Device Lot Number: 1820600005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR