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

Catalog Number	PHW18R302P
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Lesion details: patient's sfa was chronically occluded & reconstituted somewhere between the popliteral and tibial peroneal trunk.Event description: the physician was subintimal through the sfa into the popliteal and at.He was attempting to re-enter with the gaia pv at the take off of the at.The gaia pv seemed buckled and collapsed onto itself.Upon trying to remove the wire, the tip of the wire began to unravel.We were able to remove the wire via the support catheter without losing any parts of the wire.The physician was torquing the wire at a slow steady pace and is very familiar with the wire in his algorithm.Remedial action: the physician was able to remove the wire without any breaking apart of any wire pieces.Post procedure outcome: the physician was unable to reenter the true lumen distal to the cto and revascularize.
Additional Manufacturer Narrative
I would like to inform you that our recent mdr submission #3004718255-2025-00384 was submitted after the 30-day reporting guideline.The date of awareness that determined the complaint to be mdr reportable was march 6, 2025, while the mdr was submitted on may 30, 2025.Mdr determination result was inadvertently not communicated internally, which resulted in a failure to report to the fda within the required timeframe.
Event or Problem Description
Lesion details: patient's sfa was chronically occluded & reconstituted somewhere between the popliteral and tibial peroneal trunk.Event description: the physician was subintimal through the sfa into the popliteal and at.He was attempting to re-enter with the gaia pv at the take off of the at.The gaia pv seemed buckled and collapsed onto itself.Upon trying to remove the wire, the tip of the wire began to unravel.We were able to remove the wire via the support catheter without losing any parts of the wire.The physician was torquing the wire at a slow steady pace and is very familiar with the wire in his algorithm.Remedial action: the physician was able to remove the wire without any breaking apart of any wire pieces.Post procedure outcome: the physician was unable to reenter the true lumen distal to the cto and revascularize.

• 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: 22119276
• Report Number: 3004718255-2025-00384
• Device Sequence Number: 20570725
• Product Code: DQX
• UDI-Device Identifier: 04547327106917
• UDI-Public: (01)04547327106917(17)270731(10)240803A431
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025
• Report Date (Section F): 06/06/2025

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 Catalogue Number: PHW18R302P
• Device Lot Number: 240803A431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/12/2025
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 06/06/2025