MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	LA6JR40SH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/04/2020
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 to treat a non-calcified, non-tortuous mid brachial artery.There was no damage noted to the packaging, the device was removed from packaging per ifu with no issues.The device was inspected with no issues.The device was prepped per ifu with no issues.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the tip of the device was not cylindrical, but had a sharp corner that caused vessel damage/dissection.The product was replaced with a non medtronic device.The patient status post procedure is alive with no injury.
Additional Manufacturer Narrative
The dissection occurred in the brachial artery.The tip of the launcher was not noted to be sharp before it was used in the patient.A non-medtronic 6f guide catheter was being used with the launcher when the issue was noted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9797372
• Report Number: 1220452-2020-00034
• Device Sequence Number: 586006
• Product Code: DQY
• UDI-Device Identifier: 00613994817631
• UDI-Public: 00613994817631
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 06/10/2021
• Device Model Number: LA6JR40SH
• Device Catalogue Number: LA6JR40SH
• Device Lot Number: 0009780944
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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: Other
• Patient Age: 67 YR