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

Catalog Number	LA6JR40
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4): several still images were received for analysis.The first image shows both guide catheters coiled up in plastic packaging.The second image shows device details on the outer packaging, with lot# matching that of the complaint file.The third image shows a torsional kink on one of the launcher devices.It cannot be confirmed where on the device this kink is located.It is not clear from the images provide where the damage is on the second device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Two launcher guide catheters were intended to be used during a procedure.No damage was noted to packaging.The device was removed from the packaging as per ifu with issues noted.It was reported that the devices were kinked at the proximal end of the catheter prior to removal from the packaging.It was later confirmed that when the devices were introduced into the patient they did not flow normally and when removed from the patient they were noted to be damaged.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 8988004
• Report Number: 1220452-2019-00122
• Device Sequence Number: 3323601
• Product Code: DQY
• UDI-Device Identifier: 00613994817778
• UDI-Public: 00613994817778
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K132673
• 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,Followup
• Report Date (Section B): 11/04/2019

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: 09/27/2020
• Device Catalogue Number: LA6JR40
• Device Lot Number: 0009352595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 76