MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE; GUIDEWIRE, PRODUCT CODE: DQX

Model Number	OFG2524LF
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for analysis.A review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint is non-verifiable as the product was not returned for evaluation.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "device interaction", "improper handling" and/or "undetermined cause" appears to have impacted on the event as reported.Without the return of the actual device in question for evaluation, lake region medical is unable to determine the exact cause for this incident.Lake region medical has no open preventative action specific to manufacturing this product differently.
Event or Problem Description
Hello new ross complaint handling group: we have received a complaint for phoenix light support guidewire: pg14300lf, lot: 7932023 where the distal wire tip broke.A snare was attempted to remove the broken tip but was unsuccessful, thus the distal tip remained in the left femoral artery.The device will not be returned for evaluation.Please let us know if you have any further questions.Thank you.Complaint # (b)(4).Date of event: 10/07/2025.Philips reportability aware date: 10/08/2025.Country: france (fra).Nature of complaint: at the end of the procedure during the retrieval of the phoenix catheter system, the guide wire was broken in 2 parts.The distal part remained in the left femoral artery.The practician has tried to catch it with a snare but without success.Device will not be returned.Type of case: periphera.L access location: femoral.Vessel tortuosity: severe.Procedure type: therapeutic.Was resistance encountered? no.Lesion calcification: severe.Type of "target" lesion: calcified.Peripheral vessel: common femoral.Vessel segment: prox.Access approach: contralateral.Chronic total occlusion (cto)? unknown.Did an embolization occur? yes.Was the support clip used? (phoenix catheter): yes.
Event or Problem Description
Hello new ross complaint handling group: we have received a complaint for phoenix light support guidewire: pg14300lf, lot 7932023 where the distal wire tip broke.A snare was attempted to remove the broken tip but was unsuccessful, thus the distal tip remained in the left femoral artery.The device will not be returned for evaluation.Please let us know if you have any further questions.Thank you.Complaint # (b)(4) date of event: 10/07/2025.Philips reportability aware date: 10/08/2025.Country: france (fra).Nature of complaint: at the end of the procedure during the retrieval of the phoenix catheter system, the guide wire was broken in 2 parts.The distal part remained in the left femoral artery.The practician has tried to catch it with a snare but without success.Device will not be returned.Type of case: peripheral.Access location: femoral.Vessel tortuosity: severe.Procedure type: therapeutic.Was resistance encountered? no.Lesion calcification: severe.Type of "target" lesion: calcified.Peripheral vessel: common femoral.Vessel segment: prox.Access approach: contralateral.Chronic total occlusion (cto)? unknown.Did an embolization occur? yes.Was the support clip used? (phoenix catheter): yes.
Additional Manufacturer Narrative
No device was returned for analysis.A review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint is non-verifiable as the product was not returned for evaluation.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "device interaction", "improper handling" and/or "undetermined cause" appears to have impacted on the event as reported.Without the return of the actual device in question for evaluation, lake region medical is unable to determine the exact cause for this incident.Lake region medical has no open preventative action specific to manufacturing this product differently.

• Brand Name: PHOENIX GUIDEWIRE
• Common Device Name: GUIDEWIRE, PRODUCT CODE: DQX
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, irl Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, irl Y34 K 825; EI Y34 K825
• Manufacturer Contact: katie slattery ; butlersland; new ross; co. wexford, irl Y34 K-825 ; EI Y34 K825
• MDR Report Key: 23416036
• Report Number: 9681477-2025-00118
• Device Sequence Number: 9085170
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)260928(10)7932023
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080144
• 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,Followup
• Report Date (Section B): 11/11/2025

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 Expiration Date: 09/28/2026
• Device Model Number: OFG2524LF
• Device Lot Number: 7932023
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown