MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 5F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	LA5ALR12
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A launcher guide catheter was used during a procedure.There was no damage noted to the device packaging.The device was placed and contrast medium injected.It was decided to remove the device as pressure was unable to be achieved.It was reported that the device kinked while in the patient and could not be removed.The patient was sent for surgery to remove the device.Patient status is unknown at this time.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAUNCHER 5F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9178346
• Report Number: 1220452-2019-00135
• Device Sequence Number: 2763552
• Product Code: DQY
• UDI-Device Identifier: 00613994783769
• UDI-Public: 00613994783769
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2020
• Device Model Number: LA5ALR12
• Device Catalogue Number: LA5ALR12
• Device Lot Number: 0008999953
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention