MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE .014" GUIDEWIRE

Model Number	901047-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ecn event description: patient placed on table awake and alert moving all extremities.Tcar proceeded as planned and discussed with md.Tcar timeout performed and patient placed on reverse flow.Md introduced wire and 5x30 sterling balloon into sheath and advance to proximal carotid.Md noted difficulty and friction when advancing the wire to engage internal carotid (ic).Wire selected external carotid (ec) and then pulled back with md again noting difficulty.Ic was then selected and wire advanced.Balloon inflation done.Balloon removed and stent inserted, but md did not note any difficulty during device exchanged.Stent placed in ic as planned.Stent delivery system and wire removed together and 2 minute washout completed.The distal wire tip (around 5-7cm) was observed to have been mangled with the distal coils detached from shaft and core.Final angio done and we noticed small radioopaque (ro) marker on x-ray distal to the stent.Md and i believed it was in the ic due to it being over the distal ica on x-ray.Md did not change x-ray angulation after it was suggested.A new enroute 014 wire was retrieved.A 10mm snare was used in the ic to attempt to retrieve the tip but was unsuccessful.Md decided to place a 4x15 pk papyrus covered stent to jail it.Angio was done and patency of ica was observed, but it was noted that the wire was rather in the ec.The ec was engaged with the new enroute wire and a snare was used unsuccessfully to retrieve the wire tip.After consideration, it was noted to be in the ec and would likely not cause a stroke later on.Final angio was completed and all devices were removed and antegrade flow was restored after 33 minutes of reverse flow.Patient was woken from anesthesia and was able to move all extremities prior to leaving the or.I will check back on patient status in the coming days until discharge.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none what is the next course of action?: patient status follow up until discharge.Patient present at time of event?: yes patient complications: other provide details for "other" patient complication: unable to retrieve broken end of guide wire from the carotid/external carotid in the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes please describe the way in which the device or procedure caused or contributed to the patient complication?: guide wire tip fractured off medical or surgical interventions: covered stent in ica, use of snare patient outcome: expected to fully recover.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Additional Manufacturer Narrative
Complaint investigation is attached to this report.
Event or Problem Description
Ecn event description: patient placed on table awake and alert moving all extremities.Tcar proceeded as planned and discussed with md.Tcar timeout performed and patient placed on reverse flow.Md introduced wire and 5x30 sterling balloon into sheath and advance to proximal carotid.Md noted difficulty and friction when advancing the wire to engage internal carotid (ic).Wire selected external carotid (ec) and then pulled back with md again noting difficulty.Ic was then selected and wire advanced.Balloon inflation done.Balloon removed and stent inserted, but md did not note any difficulty during device exchanged.Stent placed in ic as planned.Stent delivery system and wire removed together and 2 minute washout completed.The distal wire tip (around 5-7cm) was observed to have been mangled with the distal coils detached from shaft and core.Final angio done and we noticed small radioopaque (ro) marker on x-ray distal to the stent.Md and i believed it was in the ic due to it being over the distal ica on x-ray.Md did not change x-ray angulation after it was suggested.A new enroute 014 wire was retrieved.A 10mm snare was used in the ic to attempt to retrieve the tip but was unsuccessful.Md decided to place a 4x15 pk papyrus covered stent to jail it.Angio was done and patency of ica was observed, but it was noted that the wire was rather in the ec.The ec was engaged with the new enroute wire and a snare was used unsuccessfully to retrieve the wire tip.After consideration, it was noted to be in the ec and would likely not cause a stroke later on.Final angio was completed and all devices were removed and antegrade flow was restored after 33 minutes of reverse flow.Patient was woken from anesthesia and was able to move all extremities prior to leaving the or.I will check back on patient status in the coming days until discharge.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none.What is the next course of action?: patient status follow up until discharge.Patient present at time of event?: yes.Patient complications: other provide details for "other" patient complication: unable to retrieve broken end of guide wire from the carotid/external carotid in the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes.Please describe the way in which the device or procedure caused or contributed to the patient complication?: guide wire tip fractured off medical or surgical interventions: covered stent in ica, use of snare.Patient outcome: expected to fully recover.

• Brand Name: ENROUTE .014" GUIDEWIRE
• Common Device Name: ENROUTE .014" GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer Contact: barbara krason ; parkmore west business park; galway, H91CK-22 ; EI H91CK22
• MDR Report Key: 23208369
• Report Number: 3006010712-2025-00040
• Device Sequence Number: 21122009
• Product Code: DQX
• UDI-Device Identifier: 10816349014854
• UDI-Public: (01)10816349014854(17)290228(10)9656951
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160643
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 901047-01
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 9656951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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
• Patient Sex: Unknown