MAUDE Adverse Event Report: LIVANOVA USA INC VASCULAR DILATOR KIT; ESTECH PERCUTANEOUS INSERTION DILATOR KIT

Model Number	200-120
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.The involved dilator has been disposed by the customer and thus it is not available for investigation at livanova.On april 21, 2020, livanova has received a copy of the medwatch the customer has submitted a review of the dhr did not identify any deviation or non-conformity relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available.
Event or Problem Description
Livanova usa in has received a report that, during a femoral cannulation for a procedure, the tip of the dilator cracked.According to customer information this cause patient vessel damage at the insertion point and requiring femoral venous repair during the surgery.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The complained dilator was disposed by the customer.However, the customer has provided photographic evidences showing a small crack in the tip of the complained dilator.The review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.No other complaint has been recorded for the claimed product lot.No other similar complaints have been received for claimed item.The reported failure was confirmed by visual inspection of the provided picture.However, without possibility to investigate the complained device no root cause could be assessed.This type of dilator is manufactured by a livanova supplier.The supplier was formally informed of the event and requested for investigation and to evaluate possible corrective action(s).Livanova will keep monitoring the market for similar events.H3 other text : device not available.

• Brand Name: VASCULAR DILATOR KIT
• Common Device Name: ESTECH PERCUTANEOUS INSERTION DILATOR KIT
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10051039
• Report Number: 1718850-2020-00022
• Device Sequence Number: 3293460
• Product Code: DRE
• UDI-Device Identifier: 00803622112522
• UDI-Public: (01)00803622112522(240)200-120(17)230131(10)2000800032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 200-120
• Device Lot Number: 2000800032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 90