MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	OFG2524LF
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device was flushed and prepared per the ifu, no abnormalities, engine test normal.The device was advanced over the phoenix wire to the stenosis in the arteria poplitea.Multiple atherectomy with good results.The device was advanced into the anterior tibial artery, multiple atherectomy.According to the hcp, suddenly a loud noise and resistance occured.He stopped immediately, removed the device, flushed the artery and saw the wire ripped open.He was able to remove the wire from the vessel without resistance.The patient was treated with balloon dilation.The patient is doing well.Additional information received on 10/1/2024: multiple atherectomy is stated which was meant by passes.The device were removed separately.There was no device malfunction for the phoenix catheter.Photos received on 10/2/2024: coil damage was observed but appears intact.
Additional Manufacturer Narrative
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.Device received and will be analysed shortly.
Event or Problem Description
Device was flushed and prepared per the ifu, no abnormalities, engine test normal.The device was advanced over the phoenix wire to the stenosis in the arteria poplitea.Multiple atherectomy with good results.The device was advanced into the anterior tibial artery, multiple atherectomy.According to the hcp, suddenly a loud noise and resistance occured.He stopped immediately, removed the device, flushed the artery and saw the wire ripped open.He was able to remove the wire from the vessel without resistance.The patient was treated with balloon dilation.The patient is doing well.Additional information received on 10/1/2024: multiple atherectomy is stated which was meant by passes.The device were removed separately.There was no device malfunction for the phoenix catheter.Photos received on 10/2/2024: coil damage was observed but appears intact.
Additional Manufacturer Narrative
As reported: "we have received a complaint on a phoenix light support guidewire: model: pg14300lf, lot: 7932009, where the wire ripped open.The wire was received, and decontamination was completed.Please send us a comp# and any other necessary information to send the device back.Please let us know if you have any further questions.Complaint#: (b)(4).Date of event: 20 sept 2024.Complaint aware date: 26 sept 2024.Country: germany.Nature of complaint: device was flushed and prepared per the ifu, no abnormalities, engine test normal.The device was advanced over the phoenix wire to the stenosis in the arteria poplitea.Multiple atherectomy with good results.The device was advanced into the anterior tibial artery, multiple atherectomy.According to the hcp, suddenly a loud noise and resistance occured.He stopped immediately, removed the device, flushed the artery and saw the wire ripped open.He was able to remove the wire from the vessel without resistance.The patient was treated with balloon dilation.The patient is doing well.Additional information received on 10/1/2024: multiple atherectomy is stated which was meant by passes.The device were removed separately.There was no device malfunction for the phoenix catheter.Photos received on 10/2/2024: coil damage was observed but appears intact." the sample was returned, placed in a double zip-lock type bag marked biohazard.The sample was then placed into 2 boxes which were protected with foam.The guidewire returned coiled in a circular shape.A visual and tactile examination of the returned guidewire was completed, and the following features were observed: this guidewire is a 2- piece construction: coil and core.The guidewire returned with an offset on the coil located 0.5cm from the distal weld.There were also some overstretched coils 0.3cm from the proximal joint.The coil was found to be fully intact and not fractured besides the portion of overstretched coils and the offset.A portion of a stent-like device was found to be stuck on the guidewire, from 17cm from the distal joint to 20cm from the distal joint.This device was tangled up on itself and the guidewire and had a plaque-like material stuck to it.No anomalies were observed to indicate a manufacturing issue with the distal and proximal joints.Both joints were intact.No other damage was noted on the returned product.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.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, "operational context" appears to have impacted on the event as reported.

• Brand Name: PHOENIX GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer Contact: suzanne foley ; butlersland; new ross, co. wexford Y34 K-825 ; EI Y34 K825
• MDR Report Key: 20992954
• Report Number: 9681477-2024-00022
• Device Sequence Number: 4514252
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)260903(10)7932009
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080144
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2026
• Device Model Number: OFG2524LF
• Device Lot Number: 7932009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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