MAUDE Adverse Event Report: Lake Region Medical THRUWAY¿; Wire, Guide, Catheter

Model Number	M001492971
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• Brand Name: THRUWAY¿
• Common Device Name: Wire, Guide, Catheter
• 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: 50253325
• Report Number: 2126666-2026-00049
• Device Sequence Number: 10008286
• Product Code: DQX
• UDI-Device Identifier: 08714729717188
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: M001492971
• Device Catalogue Number: M001492971
• Device Lot Number: 8486610
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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 Sex: Unknown