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

Model Number	THNDR190S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	01/15/2020
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
During treatment procedure, a symplicity spyral catheter was used to treat the right and left renal arteries.A sherpa guide catheter and three thunder guide wires were also used during the procedure it was reported that during the procedure patient suffered a dissection in the left renal branch.It was reported that a guidewire went in to the branch and at end of the case the vessel appeared to have a dissection.The dissection was wired and the flow was reestablished.The branch was also treated with rdn.Dissection was noted prior to insert the spyral catheter.Investigator assessed that event is not related to study device or therapy but definitely related to procedure.Sponsor assessed that event is related to procedure and possibly related to spyral catheter and not related to the therapy.The patient is recovered without sequelae.There is no reported malfunction for the thunder guide wires and sherpa guide catheter used during the procedure.
Additional Manufacturer Narrative
Additional information: update to patient weight.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.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.

• 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: 9687182
• Report Number: 1220452-2020-00018
• Device Sequence Number: 14288207
• Product Code: DQX
• UDI-Device Identifier: 00643169453029
• UDI-Public: 00643169453029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: THNDR190S
• Device Catalogue Number: THNDR190S
• Device Lot Number: G19A08205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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
• Patient Age: 46 YR
• Patient Weight: 158