MAUDE Adverse Event Report: LIVANOVA USA INC ESTECH PERCUTANEOUS INSERTION DILATOR KIT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	200-120
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id, age, gender, weight and ethnicity: patient information was not provided.The device has been received at livanova (b)(4).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report that, at the unpacking of the vascular dilator, the tip of the dilator was too sharp.The surgeon elected to not use the dilator.There was no patient involvement.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Livanova received a report stating that the tip of the 20fr dilator was too sharp.The issue was detected prior to patient use; no patient/user affected.The dilator was received at livanova usa.Visual inspection of the returned product found that the tip of the dilator had been slightly bent outwards perpendicular to the rest of the dilator.Dimensional analysis found the dimensions were within specification thus excluding an excessive sharpness and confirming no manufacturing deviation.The dhr review confirmed the device was released conforming to product specifications.No similar event was recorded on the same lot involved by reviewing the livanova complaints database thus confirming this is an isolated event.Based on the above, livanova believes the bent tip was the ¿sharpness¿ described by the user and was probably due to an improper or misaligned use of the guide wire with the dilator.No device issue could be confirmed.The risk is in the acceptable region.Livanova will keep monitoring the market.

• Brand Name: ESTECH PERCUTANEOUS INSERTION DILATOR KIT
• 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: 13693204
• Report Number: 1718850-2022-00025
• Device Sequence Number: 4261409
• Product Code: DRE
• UDI-Device Identifier: 00803622112522
• UDI-Public: (01)00803622112522(240)210-120(17)240731(10)2119300121
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 200-120
• Device Catalogue Number: 200-120
• Device Lot Number: 2119300121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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