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

Model Number	LA6IMAK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
During the index procedure one symplicity spyral catheter and one launcher guide catheter were used to treat the renal arteries.On the day of the procedure patient suffered renal artery spasm.It was reported that the patient became agitated due to pain during treatment and started moving both legs.This resulted in the catheter faulting interrupting the ablation.The catheter was withdrawn into the guide.Follow-up angiography showed a couple of areas of spasm in the midportion of the artery as well as near the ostium.The patient was given serial doses of intra-arterial nitroglycerin with incomplete resolution.A 4 mm x 12 mm medtronic euphora coronary balloon was inflated in the midportion of the vessel had a residual area of spasm to 4 atm for 30 seconds.It was then withdrawn to the ostium of the vessel where a 5 atm 30 second inflation was performed.Follow-up angiography after an additional 200 mcg intracoronary nitroglycerin showed widely patent areas without residual spasm.The patient has recovered.The investigator and the sponsor assessed the event as casually related to the procedure and the therapy and possibly related to the study catheter.There is no reported malfunction for the launcher guide catheter used during the procedure.The rationale of relationship to the therapy, study procedure and symplicity spyral catheter was that the spasm post-rfa compounded by movement due to pain.
Additional Manufacturer Narrative
Additional information: annex d code added.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: there were no issues noted with the euphora balloon used which successfully treated the spam.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Common Device Name: 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19174937
• Report Number: 1220452-2024-00023
• Device Sequence Number: 15408144
• Product Code: DQY
• UDI-Device Identifier: 00613994821126
• UDI-Public: 00613994821126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2024

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: 06/25/2025
• Device Model Number: LA6IMAK
• Device Catalogue Number: LA6IMAK
• Device Lot Number: 0011841558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 08/01/2024; 07/05/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/02/2024; 09/13/2024
• Date Device Manufactured: 06/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White