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

Model Number TC-XXXXX

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2020

Event Type  malfunction  

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 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.

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 Description

See initial report.

• Brand Name: THORACIC CATHETER
• Type of Device: DRAINAGE CATHETER
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10471113
• MDR Text Key: 209182250
• Report Number: 1718850-2020-00038
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00803622105975
• UDI-Public: (01)00803622105975(240)230331(17)TC-10132(10)2009000080
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1