MAUDE Adverse Event Report: ASAHI INTECC GAIA PV; GUIDE WIRE

Model Number	PHW18R302P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure the physician said the wire felt "trapped" he moves the wire and got it to release.When he did that the wire began to unravel.He was able to remove the wire without any pieces being lost.There was no adverse reaction to the patient.

• Brand Name: GAIA PV
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 15855556
• Report Number: 3004718255-2022-00281
• Device Sequence Number: 20112804
• Product Code: DQX
• UDI-Device Identifier: 04547327106917
• UDI-Public: (01)04547327106917(17)221231(10)200118A461
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2022
• Report Date (Section F): 11/23/2022

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: 12/31/2022
• Device Model Number: PHW18R302P
• Device Catalogue Number: PHW18R302P
• Device Lot Number: 200118A461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/31/2022
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/23/2022