MAUDE Adverse Event Report: MEDTRONIC, INC. LAUNCHER; CATHETER, PERCUTANEOUS

Model Number	LA6ERADL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary artery disease and hypertension.Procedure performed was percutaneous transluminal coronary angioplasty.Guide cath bent/damaged inside of packaging- found when taken out of package and was not used in any form in the patient procedure new guide cath was opened.

• Brand Name: LAUNCHER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 11146873
• Report Number: 11146873
• Device Sequence Number: 846573
• Product Code: DQY
• UDI-Device Identifier: 00613994821447
• UDI-Public: (01)00613994821447(17)220617(10)0010282290
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/07/2021
• Report Date (Section F): 01/07/2021

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 Model Number: LA6ERADL
• Device Lot Number: 0010282290
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2021
• Patient Sequence Number: 1
• Patient Weight: 116
• Date Report Sent to FDA: 01/07/2021