MAUDE Adverse Event Report: Lake Region Medical SAFARI2¿; WIre, Guide

Model Number	H74939406XS0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction

• Brand Name: SAFARI2¿
• Common Device Name: WIre, Guide
• Manufacturer (Section D): Lake Region Medical; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): Lake Region Medical; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; +1(952)641-8518
• MDR Report Key: 50216090
• Report Number: 2126666-2026-00047
• Device Sequence Number: 6098648
• Product Code: DQX
• UDI-Device Identifier: 08714729887621
• UDI-Public: (01)08714729887621(17)290420(10)10624897
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: H74939406XS0
• Device Catalogue Number: H74939406XS0
• Device Lot Number: 10624897
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2026
• 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: Unknown