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

Model Number	LA6EBU35
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An attempt was made to use one 6f launcher guide catheter during a procedure.The device was inspected before use with no issues noted.Resistance was not noted while advancing the device to the lesion.It was reported that the guide catheter was leaking blood during use.The leaking was caused by a connection problem, and the launcher could not be connected normally.It was not possible to connect the non-medtronic y-valves.The leak was noted during the device and y-valve connection, and the blood leakage was a result of the connection issues.The use of the launcher was stopped immediately.A new catheter and new y-valve were used, which were connected and used normally.Intervention was not required as a result of the event.There was no injury to the patient.
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.
Additional Manufacturer Narrative
Additional information: a video provided showed the proximal end of the guide catheter with a y-valve attached to its hub.There is no evidence of a leak in the video however there appeared to be an issue keeping the y-valve connected.Initial reporter name and phone number 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.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19678445
• Report Number: 9612164-2024-03126
• Device Sequence Number: 3115851
• Product Code: DQY
• UDI-Device Identifier: 00763000705374
• UDI-Public: 00763000705374
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2025
• Device Model Number: LA6EBU35
• Device Catalogue Number: LA6EBU35
• Device Lot Number: 226506984
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/30/2024
• Date Device Manufactured: 05/03/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 48 KG