MAUDE Adverse Event Report: LIVANOVA USA INC. VASCULAR DILATATOR KIT 24F; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	200-120
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova usa inc.Manufactures the vascular dilatator kit 24f.The incident occurred in (b)(6), france.The customer returned the 24 fr dilator, while the guide wire was not returned for investigation.Investigation of the returned dilator revealed a crack in the tip.Involved affected part belongs to the dilators kit code 200-120 and is manufactured by a supplier.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc.Received a report that a 24french drain plug dilator was cracked at the end during normal use on a stiff guide.There is no patient injury.
Additional Manufacturer Narrative
Visual inspection on returned unit (24 fr dilator) revealed a crack at the tip, that according to event description, occurred during use with the guide wire, that was found particularly stiff by the customer.Involved guide wire was not returned for investigation.Involved product is part of the dilators kit code 200-120 and is supplied by a qualified livanova supplier.From the review of the database, no other similar complaint has been recorded for this same lot, nor a concerning trend has been identified.Based on the above facts, it cannot be ruled out that the most likely root cause of the event could be traced back to an improper or misaligned use of the guide wire with the dilator, where the tip was forced against the guide wire when it was not parallel to the dilator, causing the crack.However, considering that the guide wire has not been returned, a possible defective guide cannot be excluded.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: VASCULAR DILATATOR KIT 24F
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): LIVANOVA USA INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20854531
• Report Number: 1718850-2024-00046
• Device Sequence Number: 8905208
• Product Code: DRE
• UDI-Device Identifier: 00803622112522
• UDI-Public: (01)00803622112522(240)200-120(17)270211(10)2404300175
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/27/2025

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 Model Number: 200-120
• Device Lot Number: 2404300175
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown