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

Model Number	M001492971
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a reported complex atherectomy procedure involving a severely calcified, moderately tortuous distal superficial femoral artery (sfa) lesion with 100% stenosis, the physician advanced the jetstream atherectomy too far, resulting in fracture and detachment of the distal tip of the guidewire, with the fractured segment remaining within the patient.An attempt was made to retrieve the detached wire tip using a snare; however, retrieval was unsuccessful.As stent implantation was already planned, the detached wire fragment was secured against the vessel wall with the implanted stent.No additional actions were taken.No patient effects were reported.
Additional Manufacturer Narrative
Product was disposed; therefore, no physical or visual analysis could be performed.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that procedural and/or clinical factors have contributed to the event as reported.We reviewed the associated risk documentation relative to this product and confirmed that this incident is listed and that it is trending within the established occurrence threshold.Patient information was not provided; therefore, part a could not be completed.The sections left blank or unknown on this form could not be completed due to missing information.Attempts were made to obtain additional details; however, no further information was provided.Should additional information be received, a follow-up medwatch report will be submitted.Although annex g instructions state that with stand-alone devices annex g term should not be used, code 4755 was selected because the system requires a value in h6(g).

• 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: 50883381
• Report Number: 2126666-2026-00054
• Device Sequence Number: 10707859
• Product Code: DQX
• UDI-Device Identifier: 08714729717188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: M001492971
• Device Catalogue Number: M001492971
• Device Lot Number: 10149934
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown