MAUDE Adverse Event Report: ASAHI INTECC CO LTD MEISTER 16; GUIDEWIRE

Catalog Number	WAMS-180-16WA
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Wire became unraveled during use.The wire was noticed as it was unraveling as they were pulling it out of the progreat catheter.They pulled the wire out and replaced it with a new wire to continue case.

• Brand Name: MEISTER 16
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC CO LTD; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 24382134
• Report Number: 3004718255-2026-00007
• Device Sequence Number: 10504527
• Product Code: DQX
• UDI-Device Identifier: 04547327108348
• UDI-Public: (01)04547327108348(17)280831(10)250911A30A
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/18/2026
• Report Date (Section F): 02/18/2026

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: WAMS-180-16WA
• Device Lot Number: 250911A30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/30/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• 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: 02/18/2026