MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 7F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	LA7EBU30
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A la7ebu30 launcher guide catheter was used for a physician-evaluated cadaver study as part of a pre-clinical study.The unit was removed from packaging with no issues noted.The physician inserted the guide catheter through an introducer into the right femoral artery.The physician tracked the device into the coronary ostium and spent approx.10 minutes attempting to cannulate the left coronary artery.The physician was unable to place the guide catheter tip within the coronary artery.They attempted to inject some contrast through the guide and noted that they could not inject.There was some obstruction and they thought the guide might be kinked.The unit was removed from the cadaver model.On removal, it was noted that flattening and torsional kinking of the unit had taken place.It is indicated that the device was not excessively torqued.
Additional Manufacturer Narrative
Image review: the image provided by the customer shows two 7f launcher catheters.One of the catheters is badly damaged.The image shows the distal end of the catheter, a section approx.15cm in length crushed flat and torqued.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAUNCHER 7F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8310163
• Report Number: 1220452-2019-00012
• Device Sequence Number: 11292799
• Product Code: DQY
• UDI-Device Identifier: 00613994834782
• UDI-Public: 00613994834782
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K022764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 04/09/2020
• Device Catalogue Number: LA7EBU30
• Device Lot Number: 0009077577
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 77