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

Model Number	LA6ERADL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with new onset of chest pain was admitted for a cardiac catheterization with percutaneous intervention.Phd device would not stay on the medtronic launcher 6f coronary guide catheter erad left short tip.The phd was used on another guide catheter without issue.No known harm to patient.

• Brand Name: LAUNCHER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11929700
• Report Number: 11929700
• Device Sequence Number: 3237207
• Product Code: DQY
• UDI-Device Identifier: 00613994821447
• UDI-Public: (01)00613994821447(17)230308(10)0010594580
• 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): 05/20/2021
• Report Date (Section F): 05/20/2021

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: 0010594580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/20/2021