MAUDE Adverse Event Report: PHENOX LTD PORTAL STEERABLE HYDROPHILIC GUIDEWIRE; CATHETER GUIDE WIRE

Model Number	PORT-14-200-1
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information to be provided pending device return and analysis.
Event or Problem Description
It was reported that during a stroke thrombectomy, dr.Advanced a portal wire in a somewhat tortuous anatomy.Upon torquing the device to the m1 the wire "popped".He had the wire inside a microcatheter inside a guide.The fracture took place 30cm from the proximal in the common.Microcatheter was removed and a thrombectomy device was used to pin the wire fragment inside of the guide.The wire was successfully retrieved with no other damage or consequence to the patient or procedure.
Event or Problem Description
This is a follow up report - see intinal report for this information.
Additional Manufacturer Narrative
Corrected data in following fields d2 common name device d9 device available for evaluation h3 device evaluated by manufacturer h6 adverse event code medical device problem code.Type of investigation.Investigation findings.Investigations conclusions.

• Brand Name: PORTAL STEERABLE HYDROPHILIC GUIDEWIRE
• Common Device Name: CATHETER GUIDE WIRE
• Manufacturer (Section D): PHENOX LTD; kamrick court; ballybrit business park; galway, co galway H91XY 38; EI H91XY38
• MDR Report Key: 11164795
• Report Number: 3013656790-2021-00001
• Device Sequence Number: 14144789
• Product Code: DQX
• UDI-Device Identifier: 05391530910040
• UDI-Public: (01)05391530910040(17)220208(10)5090899
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2022
• Device Model Number: PORT-14-200-1
• Device Lot Number: 5090899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention