MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	LA6EBU35SH
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a launcher guide catheter.The device was inspected prior to use and prepped with no issues noted.Resistance was noted when advancing the launcher in the vessel.Excessive force was not used.Resistance was encountered when a standard size guide liner was inserted into the launcher guide catheter and the guide liner could not be advanced.On removal of the guide liner from the guide catheter, the tip of the guide catheter was noted to be kinked and split.No patient injury reported.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6731820
• Report Number: 1220452-2017-00069
• Device Sequence Number: 16417809
• Product Code: DQY
• UDI-Device Identifier: 00613994821324
• UDI-Public: 00613994821324
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K021256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2017

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: 12/19/2018
• Device Catalogue Number: LA6EBU35SH
• Device Lot Number: 0008424001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1