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

Catalog Number	LA6AR10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/22/2016
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 device was intended to be used to treat a lesion in the rca.No damage noted to packaging.The device was removed from the packaging as per ifu.The device was inspected with no issues noted.The device was prepped as per ifu.The patient had an unusual departure of the coronary artery from the aorta which caused the guide catheter to become twisted during intubation.During use, the catheter was partially torn in the right iliac arterty.The attempt to remove the catheter part was made during another surgery, using fiberoscopes pliers.The issue was considered to be related to the patient anatomy and not to the product itself.No further patient injury reported.

• 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: 8101559
• Report Number: 1220452-2018-00136
• Device Sequence Number: 1057909
• Product Code: DQY
• UDI-Device Identifier: 00613994820433
• UDI-Public: 00613994820433
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 11/26/2018

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: 06/23/2017
• Device Catalogue Number: LA6AR10
• Device Lot Number: 0007627004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 11/26/2018
• 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
• Patient Age: 52 YR