MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV Sherpa Balanced 6F Guide Catheter; CATHETER, PERCUTANEOUS

Model Number	SB6AL75
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Positioning Problem (3009)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Vascular Dissection (3160)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure via the right femoral access, difficult catheter manipulation was encountered with a 7f sherpa catheter in the setting of vascular tortuosity.The sherpa guide catheter was noted to be kinked under fluoroscopy.Subsequent an giography identified a right iliac/femoral spiral dissection.The patient underwent ct for concern of claudication/leg ischemia related to retrograde right femoral dissection and then underwent vascular/interventional radiology intervention with angioplasty and ri ght external iliac stenting.The patient did well and was discharged the following day.No further patient complications were reported.
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.

• Brand Name: Sherpa Balanced 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 ; +353(091)708096
• MDR Report Key: 50785213
• Report Number: 9617601-2026-05652
• Device Sequence Number: 13389655
• Product Code: DQY
• UDI-Device Identifier: 00763000893408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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 Model Number: SB6AL75
• Device Catalogue Number: SB6AL75
• Device Lot Number: 232854592
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 12/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male