MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. MEISTER 16; PERIPHERAL GUIDE WIRE

Model Number	WAMS-180-16WA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: 3009121749.When the reported product was returned to the manufacturer, reportable malfunction was recognized for the first time; therefore, g3.Date received by manufacturer is the same as the date in d9.Returned to manufacturer.The reported meister 16 guide wire was returned for evaluation.The polymer jacket of the returned meister 16 guide wire was torn at approximately 180mm distal to the proximal solder (set at 300mm from the wire tip to fix the outer coil onto the core wire).The outer coil was distally stretched for approximately 190mm from approximately 180mm distal to the proximal solder.The polymer fragments were found intermittently adhered on the outer coil.The core wire was found fractured and exposed for approximately 43mm at approximately 180mm distal to the proximal solder.The ball tip was confirmed at the very distal end of the stretched outer coil, indicating that the outer coil was intact.Microscopic observation of the exposed core wire fracture end found an irregular fracture surface and circumferential cracks on the shaft proximal to the fracture end, likely caused by repeated compressing bending stress.To confirm the distal side of the core wire fracture end, the polymer jacket at the distal segment of the outer coil was removed.The core wire was found fractured at approximately 68mm from the wire tip proximal to the inner coil.Microscopic observation of the fracture end of the core wire on the distal side found an irregular fracture surface and circumferential cracks on the shaft distal to the fracture end, just as observed with the proximal side of the core wire fracture end, likely caused by repeated compressing bending stress.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the obtained information and investigation outcome, it was presumed that repeated compressive bending stress generated with guide wire manipulation might have been locally applied to the proximal segment of the inner coil, where stiffness varies, of the subject meister 16 guide wire.Consequently, the core wire was fractured, reducing operability.As stress was applied during withdrawal attempts, the outer coil and polymer jacket were significantly stretched.It was concluded that the reported event was not attributed to the product quality.Given the severe damage observed on the returned guide wire, it was unable to completely rule out a possibility that some polymer fragment(s) might be left in the patient anatomy.No capa will be taken.The instructions for use (ifu) states: [warnings] ~ if this guide wire meets resistance or any anomaly during use, do not continue operation.If it is suspected that the guide wire is not normally operating, do not continue to operate the guide wire.While paying much attention to possible complications, carefully withdraw the whole system.~ observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire.[malfunctions and adverse effects] ~ break apart.
Event or Problem Description
It was reported that an asahi meister 16 guide wire had unravelled when taken out of the concomitant progreat microcatheter (terumo) during a prostatic artery embolization (pae).No other information on the event was available.The procedure was continued with a new unspecified guide wire and was completed successfully.It was informed that there were no adverse patient effects associated with this event and the patient was discharged after the procedure.

• Brand Name: MEISTER 16
• Common Device Name: PERIPHERAL GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 24451123
• Report Number: 3003775027-2026-00030
• Device Sequence Number: 10007452
• 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
• PMA/510(K) Number: K161584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown