MAUDE Adverse Event Report: LIVANOVA USA INC THORACIC CATHETER

Model Number	TC-XXXXX
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: THORACIC CATHETER
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada 80004
• MDR Report Key: 8478756
• Report Number: 1718850-2019-00009
• Device Sequence Number: 11254305
• Product Code: DWF
• UDI-Device Identifier: 00803622105975
• UDI-Public: (01)00803622105975(240)TC-10132(17)211130(10)1833100059
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1