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

Model Number	PORT-14-200-1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following description was provide from the healthcare professional: "they started to use the portal, and before reached the lesion, realized that the guide wire portal had broken in half.They didn't push or did any pression and feel any kinking because the anatomy wasn't complex.They tried to pull it out with a solitaire, a snare and it didn't work.They ended up using a derivo´s flow diverter.The patient was hospitalised for 1 day, as usual." during the procedure, one portal guidewire was used and, before the device reached the lesion, it was noted that the portal wire had broken in half.A microcatheter was also used during the procedure.It was reported that the device was not pushed and no pressure was added.Kinking was not felt as patient's anatomy was not complex.An attempt was made to remove the detached portion of the device using a thrombectomy retriever and snare but the attempt was not successful.A flow diverter device was then used and the detached part of the portal device was successfully removed from the patient.There was no prolongation of patient hospitalization and no further injury was reported.The additional information will be obtained, and investigation performed to determine if serious injury can be attributed to portal device and/or combination of devices used during procedure and/or user error.
Event or Problem Description
At a later date it was clarified that: during the same procedure, microsnare and solitaire were attempted but were not successful to remove the fractured distal fragment of the guidewire (± 12 cm).Flow diverter device (derivo) was then also used however, physician wasn't successful at removing the detached part of portal guidewire.The fractured distal piece was left in the patient and fixed in position in the artery for endothelialisation purpose.Patients condition was stable after the procedure.Proximal fragment of the device was removed and returned to phenox ltd.For analysis.Investigation to be performed on the affected device returned to the manufacturer for analysis.

• Brand Name: PORTAL
• Common Device Name: PORTAL STEERABLE HYDROPHILIC GUIDEWIRE
• Manufacturer (Section D): PHENOX LIMITED; ballybrit business park; galway city, co. galway H91 X Y38; BR H91 XY38
• Manufacturer (Section G): PHENOX LIMITED; kamrick court; ballybrit business park; galway city, co. galway H91 X Y38; EI H91 XY38
• MDR Report Key: 17841578
• Report Number: 3013656790-2023-00007
• Device Sequence Number: 4401839
• Product Code: DQX
• UDI-Device Identifier: 05391530910040
• UDI-Public: (01)05391530910040(17)250915(10)8453187
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 09/15/2025
• Device Model Number: PORT-14-200-1
• Device Lot Number: 8453187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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
• Patient Sex: Unknown