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

Model Number	200-120
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided.Contact telephone number: (b)(6).During follow-up communication with the customer, it was reported that the device was available for return.However, due to blood borne pathogen contamination, the product could not be returned.The customer reported that the patient had been transferred from another hospital and that it is not believed that the guide wire was to blame for the patient death, which occurred following the procedure reportedly due to an unrelated medical condition.Customer photographs were provided, which confirmed the reported issue.Research into this product found that in the past two years, over 52,000 guide wires have been consumed at livanova into various kits.This is the only complaint received within that time frame for unraveling.An outside manufacturer provides the 180cm guide wire for incorporation into the dilator kit.A description of the customer¿s complaint and the photographs of the unraveled device have been forwarded to them through a supplier quality notification.As the device could not be returned for investigation, a root cause was not determined.Device blood borne pathogen contaminated.
Event or Problem Description
Livanova received a report that the guide wire of the estech percutaneous insertion dialator kit unraveled as it was being removed from the patient during a procedure.No patient injury was reported as a result of the event.However, it has been reported that the patient later expired due to a medical condition.

• Brand Name: ESTECH PERCUTANEOUS INSERTION DIALATOR KIT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): LIVANOVA USA; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6926968
• Report Number: 1718850-2017-00017
• Device Sequence Number: 16348468
• Product Code: DRE
• UDI-Device Identifier: 00803622112522
• UDI-Public: (01)00803622112522(240)200-120(17)200630(10)1717800119
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2017

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: 06/30/2020
• Device Model Number: 200-120
• Device Catalogue Number: 200-120
• Device Lot Number: 1717800119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1