MAUDE Adverse Event Report: PHENOX LIMITED PORTAL STEERABLE HYDROPHILIC GUIDEWIRE; WIRE.GUIDE.CATHETHER.

Model Number	PORT-14-200-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial event as reported: it was reported that a microguide 0.014 portal, was broken inside a vasco 10 microcatheter and became an intravascular foreign body in the cerebral arteries.The reason for treatment was cerebral embolization.Additional information was received on 30-jun-2025 as requested by the manufacturer: prior to the procedure, the entire guidewire was sufficiently hydrated in physiological solution in accordance with the device's instructions for use (ifu).The tip was shaped using the provided insertion tool before use.No damage, such as kinks, was noted on the guidewire before the procedure.The guidewire was not removed or reinserted during the procedure, and therefore was not re-examined or wiped with gauze at any point.The user did not experience resistance during either advancement or retraction of the guidewire.There was no advancement or withdrawal against resistance within the patient's anatomy, and the guidewire was not excessively rotated during navigation.The procedure was conducted under continuous fluoroscopic monitoring.An ancillary device, a vasco 10 microcatheter (balt), was used in conjunction with the guidewire.This microcatheter was hydrated before use, and no damage (e.G., kinks) was noted before or after its use.It is reported that the patient has no known pre-existing conditions or medical history that would have contributed to an unsuccessful device use.The guidewire fractured at the distal end, and intervention was required to retrieve the broken fragment.A balt catchview stent retriever was used successfully to extract the broken portion of the guidewire from the patient.The procedure was completed using a synchro microguidewire, and no further complications occurred after retrieval.It is reported that the patient remains stable following the event.

• Brand Name: PORTAL STEERABLE HYDROPHILIC GUIDEWIRE
• Common Device Name: WIRE.GUIDE.CATHETHER.
• Manufacturer (Section D): PHENOX LIMITED; kamrick court; ballybrit business park; galway, co.galway H91 X Y38; EI H91 XY38
• Manufacturer (Section G): PHENOX LIMITED; kamrick court; ballybrit business park; galway, co.galway H91 X Y38; EI H91 XY38
• Manufacturer Contact: patricia akamnonu ; kamrick court; ballybrit business park; galway, co.galway H91 X-Y38 ; EI H91 XY38
• MDR Report Key: 22383093
• Report Number: 3013656790-2025-00001
• Device Sequence Number: 12507235
• Product Code: DQX
• UDI-Device Identifier: 05391530910040
• UDI-Public: (01)05391530910040(17)251125(10)8510542
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K191687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: 11/25/2025
• Device Model Number: PORT-14-200-1
• Device Catalogue Number: PORT-14-200-1
• Device Lot Number: 8510542
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: Required Intervention; Other
• Patient Sex: Female