MAUDE Adverse Event Report: LIVANOVA USA, INC. TUNNELER MODEL 402

Model Number 402

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

It was reported that tunneler inner packaging did not have a tight seal and then a piece of the tunneler could be seen sticking out.The device history records of the tunneler were reviewed.The tunneler passed all inspections prior to release and was hp sterilized.No additional relevant information has been received to date.

Event Description

Suspect product was received into by manufacturer and is undergoing product analysis.No additional relevant information has been received to date.

Event Description

Tunneller product analysis (pa) was completed and reviewed.The product box has wrinkles/creases and damage on one corner in the vicinity of the opening tabs.Both product trays were identified to be open showing approximately 90% of the tyvek lid removed.Visual examination of the trays show evidence that both product trays were sealed completely at one point in time.Visual examination of the tunneling tool threaded portion shows what appear to be kinks on the 2nd, 3rd, and 4th threads.Also, the shaft threaded portion shows minor signs of gouging on the 2nd and 3rd threads.The bullet was inserted completely in the tunneling tool and removed with no anomalies identified.The observed damage to the bullet suggests that the tool was attempted to be used at one point in time.No additional relevant information has been received to date.

• Brand Name: TUNNELER MODEL 402
• Type of Device: TUNNELER
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14190418
• MDR Text Key: 289961713
• Report Number: 1644487-2022-00479
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2022

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: Other
• Device Expiration Date: 03/13/2023
• Device Model Number: 402
• Device Lot Number: 3695158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/06/2022; 06/28/2022
• Supplement Dates FDA Received: 05/31/2022; 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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