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

Model Number	VT-XXXXX
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The involved device has been requested for return to livanova for evaluation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
Event or Problem Description
Livanova received a report that the vent valve of the malleable vent catheter separated from the device during a procedure.The device was changed out without delay as soon as the issue was detected.There was no report of patient injury.
Additional Manufacturer Narrative
One malleable vent catheter was returned to livanova for evaluation.Visual inspection identified that the connector was completely detached from the catheter tubing.No evidence of uv adhesive was present at the connection site.This lack of adhesive application was a manufacturing error.The individual responsible for this portion of the catheter assembly was identified based on the reported lot number and the possible causes for this error were discussed.Remedial training was performed to ensure that the proper steps needed for this product were clearly understood.

• Brand Name: MALLEABLE VENT CATHETER
• 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: 7008450
• Report Number: 1718850-2017-00019
• Device Sequence Number: 11163125
• Product Code: DWF
• UDI-Device Identifier: 00803622106378
• UDI-Public: (01)00803622106378(240)VT-63218(17)200531(10)1713500245
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981601
• 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,Followup
• Report Date (Section B): 01/17/2018

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: 05/31/2020
• Device Model Number: VT-XXXXX
• Device Catalogue Number: VT-63218
• Device Lot Number: 1713500245
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1