MAUDE Adverse Event Report: LIVANOVA USA INC THORACIC CATHETER; DRAINAGE CATHETER

Model Number	TC-XXXXX
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was identified prior to any patient involvement (unpacking).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested at livanova usa inc for investigation.Investigation is ongoing.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not yet returned.
Event or Problem Description
Livanova has received a report that the catheter thoracic 32fr x 20in straight flared end (catalogue number tc-10132, lot 2009000080) contained a thoracic catheter french 28fr instead of french 32fr as per labelling.There is no report of any patient injury.
Additional Manufacturer Narrative
The complaint was confirmed through the analysis of provided picture.The dhr review was carried out: the lot was released as conform according to the specifications.No deviation, non-conformity, or material scrap/requests relevant to the reported issue was identified.No further similar complaint in the last 12 months occurred for the claimed code.Based on the internal investigation the most probable root cause for the complained failure was a mix-up problem occurred during kitting process.In particular, the manufacturing personal pulled the wrong product, the 28fr cannula, instead of the 32fr cannula, and allocated those to the shop order.To prevent recurrence of the complained failure, a capa activity has been initiated.Despite the risk level associated to this issue is low, to remove the affected devices from the market, a field action was initiated.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: THORACIC CATHETER
• Common Device Name: DRAINAGE CATHETER
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10471113
• Report Number: 1718850-2020-00038
• Device Sequence Number: 19719258
• Product Code: GBX
• UDI-Device Identifier: 00803622105975
• UDI-Public: (01)00803622105975(240)230331(17)TC-10132(10)2009000080
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 08/05/2020

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: 03/31/2023
• Device Model Number: TC-XXXXX
• Device Catalogue Number: TC-10132
• Device Lot Number: 2009000080
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1