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

Model Number	LA6JR40
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Ebu catheter was defective.Flattened in the middle and did not allow for passage of guide extension.We need guide extension for support but the flattened region of the 6 fr ebu 3.5 catheter hindered delivery of both guideliner and telescope.We had to take the catheter out, coronary wire out.Re engage with another guide catheter and rewire the vessel.

• Brand Name: LAUNCHER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne mvs46; moundsview MN 55112
• MDR Report Key: 14309587
• Report Number: 14309587
• Device Sequence Number: 17471180
• Product Code: DQY
• UDI-Device Identifier: 00763000508395
• UDI-Public: (01)00763000508395
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 04/25/2022
• Report Date (Section F): 04/25/2022

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
• Device Model Number: LA6JR40
• Device Lot Number: 0011088021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 04/25/2022