MAUDE Adverse Event Report: LIVANOVA USA INC THORACIC CATHETER

Model Number TC-XXXXX

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Attempts to identify the initial reporter are on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

On march 05th, 2019, livanova usa inc has received by mail post a report (mw5084514) that a thoracic catheters, straight, 32 fr was not marked with manufacturer name and size, and drainage holes were not completely punched through.According to the received information, the device was replaced.There is no report of any patient injury.

Manufacturer Narrative

Livanova was informed the complained device was not available for investigation.No photographic evidence and no other device belonging to the complained lot was available.A review of the dhr did not identify any deviation or non-conformity relevant with the case.As device investigation could not be performed, the claimed issue could not be confirmed.The subassembly of the claimed item is obtained by a livanova supplier and the supplier has been made aware of the case.Supplier manufacturing floor will be retrained on correct clustering of non-conforming material.Frequency of this type of event is low (one other similar case in the last 3 years).No other corrective action will be undertaken.Livanova will keep monitoring the market.Device not available.

• Brand Name: THORACIC CATHETER
• Type of Device: THORACIC CATHETER
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada 80004
• Manufacturer (Section G): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: alessandro melchiorre ; 14401 w 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8478756
• MDR Text Key: 143979489
• Report Number: 1718850-2019-00009
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622105975
• UDI-Public: (01)00803622105975(240)TC-10132(17)211130(10)1833100059
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

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
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Model Number: TC-XXXXX
• Device Catalogue Number: TC-10132
• Device Lot Number: 1833100059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1