MAUDE Adverse Event Report: MEDTRONIC, INC THUNDER GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number	THNDR190S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The left and right renal arteries were treated with a spyral renal denervation catheter.A thunder guidewire was used during the de nervation case and a dissection occurred.The medical advisor of the study assessed that the cause was most likely due to vessel dissection due to a guidewire.No change in procedure or treatment specific to the dissection was done.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: THUNDER GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6489271
• Report Number: 1220452-2017-00027
• Device Sequence Number: 11173060
• Product Code: DQX
• UDI-Device Identifier: 20643169453023
• UDI-Public: 20643169453023
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K970466
• 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): 03/15/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2018
• Device Catalogue Number: THNDR190S
• Device Lot Number: G15A11147
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: Hospitalization
• Patient Age: 52 YR
• Patient Weight: 83