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

Model Number VT-XXXXX

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

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 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.

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
• 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: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7008450
• MDR Text Key: 92473879
• Report Number: 1718850-2017-00019
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622106378
• UDI-Public: (01)00803622106378(240)VT-63218(17)200531(10)1713500245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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