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

Model Number LA5ALR12

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAUNCHER 5F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9178346
• MDR Text Key: 161942583
• Report Number: 1220452-2019-00135
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00613994783769
• UDI-Public: 00613994783769
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2019
• Date Device Manufactured: 02/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention