MAUDE Adverse Event Report: LAKE REGION MEDICAL THRUWAY GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	M001492981
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The physician advanced the thruway guidewire to the pedicle artery very distal to the atherectomy treatment zone.After purging the jetstream device, he proceeds to advance it over the thruway guidewire without difficulty.Once the atherectomy therapy starts, advance the device for 2 minutes, when retracting it with the rex function, it is evident that the guidewire is completely returned with the atherotome, it does not slide.The entire system had to be removed and too much traction force had to be used to extract the guidewire from the jetstream.What troubleshooting steps, if any, resolved the issue?: the guide was removed and the device was purged twice.A new guide was passed.Patient complications: no patient complications.Question: was the device removed from the patient intact? answer: yes.Question: was the guidewire able to be removed from the device once outside the patient? answer: yes, with considerable force.Question: was there any visible damage to the device? if yes, please describe: answer: no.Question: was the guidewire entrapped within the anatomy or other device? provide device details if within another device.Answer: the guide was stuck inside a jetstream 2.1mm/3.0mm atherotome.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation; therefore, no physical or visual analysis of the product 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.As noted in the device instructions for use (dfu), "free movement of the guidewire within the catheter is an important feature of a steerable guidewire system because it gives the user valuable tactile information.Test the system for any resistance prior to use." at this time, it is not possible to assign a definitive root cause for the event as reported.If there is any further information received, a follow up medwatch report will be submitted.

• Brand Name: THRUWAY GUIDEWIRE
• 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 ; 9526418518
• MDR Report Key: 17881636
• Report Number: 2126666-2023-00066
• Device Sequence Number: 15308066
• Product Code: DQX
• UDI-Device Identifier: 08714729717195
• UDI-Public: 08714729717195
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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 Expiration Date: 02/28/2026
• Device Model Number: M001492981
• Device Catalogue Number: 49-298
• Device Lot Number: 783402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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 Age: 76 YR
• Patient Sex: Female