MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	LA6AL20
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving one 6f launcher guide catheter, a kink occurred while in the patient approximately 12 inches from the hub and removal difficulties were encountered.The lesion being treated was moderately tortuous, mildly calcified with 90% stenosis in the mid right coronary artery (rca).The device was inspected prior to use with no issues noted.The device was prepped per ifu with no issues noted.Resistance was not encountered when advancing the device and excessive force was not used during insertion/delivery.No excessive force was used and the device was not excessively torqued.It was noted to be difficult to pass the wire through the launcher guide catheter and a kink was noted on the x-ray.It was reported to be difficult to remove the launcher guide catheter for approximately 5 minutes.It was eventually possible to advance the sheath over the kink to remove the catheter from the body.There was no harm to the patient and it was possible to resume the case with another launcher guide catheter of the same model.There were no patient complications reported as a result of this event.
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
Image analysis: images received depict a launcher guide catheter in a clear plastic bag.Kinks and flattening are evident to the catheter shaft.Additional information: the guidewire used was a non-medtronic wire.The non-medtronic guidewire was examined and flushed before use with no issues or kinks noted.Resistance was experienced during removal and excessive force was not used.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
Product analysis: the device returned for evaluation.A flattened section was noted on the shaft of the device approximately 10.5cm distal to the strain relief.A torsional kink with exposed braid, was noted on the shaft of the device from approximately 78cm to 79cm distal to the strain relief.No other deformation noted to the remainder of the device.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 S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24332256
• Report Number: 9617601-2026-01190
• Device Sequence Number: 4812674
• Product Code: DQY
• UDI-Device Identifier: 00763000897987
• UDI-Public: (01)00763000897987(17)270716(10)231837579(20)01
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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 Model Number: LA6AL20
• Device Catalogue Number: LA6AL20
• Device Lot Number: 231837579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 04/02/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/11/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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 Sex: Male