MAUDE Adverse Event Report: PHENOX LIMITED PORTAL STEERABLE HYDROPHILIC GUIDEWIRE; NEUROVASCULAR GUIDEWIRE

Model Number	PORT-14-200-1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Following the complication during the endovascular procedure ,where a portion of the portal guidewire (distal segment) detached and remained within the internal carotid artery-the physician took immediate remedial steps to ensure patient safety and complete the treatment without adverse outcomes.The detached segment of the microguide was promptly identified as residing in the cerebral vasculature (middle cerebral artery),.The physician attempted 3 interventional techniques to retrieve the retained fragment: an inflated balloon was used in an attempt to dislodge and withdraw the guide segment.Snare catheter retrieval for mechanical capture.A stent retriever was deployed as a final maneuver, which successfully retrieved the retained fragment.Sofia distal access catheter and neuron max sheath supported procedural success.Based on the initial information provided - the patient experienced no neurological deficits, indicating that the remedial actions were effective and did not compromise patient safety.

• Brand Name: PORTAL STEERABLE HYDROPHILIC GUIDEWIRE
• Common Device Name: NEUROVASCULAR GUIDEWIRE
• Manufacturer (Section D): PHENOX LIMITED; kamrick court,; ballybrit business park; galway, galway H91XY 38; EI H91XY38
• Manufacturer (Section G): PHENOX LIMITED; kamrick court; ballyrit business park; galway, galway H91 X Y38; EI H91 XY38
• Manufacturer Contact: rachel mcdaid ; kamrick court; ballyrit business park; galway, galway H91 X-Y38 ; EI H91 XY38
• MDR Report Key: 22479890
• Report Number: 3013656790-2025-00002
• Device Sequence Number: 7942600
• Product Code: MOF
• UDI-Device Identifier: 05391530910040
• UDI-Public: (01)05391530910040(17)260108(10)8645417
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: 01/08/2026
• Device Model Number: PORT-14-200-1
• Device Lot Number: 8646417
• 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: 06/13/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown