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

Model Number	WAMS-180-16ST
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coating on an asahi meister 16 guide wire came of inside a concomitantly used progreat microcatheter (terumo) during an angiography for a mildly calcified 75% or less stenosis with moderate tortuosity in the prostatic artery.The peeled coating was not completely detached and was not left in situ it was informed that there were no adverse patient effects associated with this event and the patient was stable without issue after the procedure.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: (b)(4).Device evaluation could not be performed because the affected device was not returned.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.The cause of the reported event could not be identified as the subject device had not been yet returned to the manufacturer.Based on the obtained informationk and referring to known similar events, it was presumed that frictional stress generated with guide wire manipulation might have been locally applied to the surface of the subject meister 16 guide wire while the lumen of the concomitantly used progreat microcatheter was reduced in size as the catheter shaft had been crushed or deformed due to anatomical conditions.Consequently, the polymer jacket of the subject meister 16 guide wire was peeled.Although it was concluded that the reported event was not attributed to the product quality, it was concluded that the polymer fragment was left in situ could not be completely ruled out as the affected device has not been returned yet.Capa: 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 the manipulation.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.[malfunction and adverse effects] damage.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: 3009121749.Investigation result: the reported meister 16 guide wire was returned for investigation.The returned meister 16 guide wire was found deformed in a crank-like shape at approximately 230mm from the wire tip.The guide wire was bent at approximately 340mm from the wire tip.The polymer jacket of the guide wire was found torn at approximately 375-390mm from the distal end of the guide wire and distally gathered.Microscopic observation of the deformed segment found disarranged coils at approximately 230mm and 235mm from the wire tip.No such damage as torn polymer jacket was observed.Microscopic observation of the proximal side of the torn polymer jacket found a trace of ductile fracture and trace of fixture and torsion.Microscopic observation of the distal side of the torn polymer jacket found a trace of ductile fracture.The polymer jacket was distally gathered at approximately 4-10mm from its distal torn end and torn just distal to the distal end of the gathered polymer.The polymer jacket was again further distally gathered for approximately 3mm from the first distal torn end of the gathered polymer.Replication test: replication test was performed as per the known similar cases.An unused guide wire of the same brand was inserted into a torque device.The torque device was slightly loosened, rotated, and slid over the wire surface so that its chuck would scrape the wire surface.As a result, similar polymer jacket damage that was seen on the returned guide wire was observed on the sample guide wire.Lot history record review: lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Conclusion: based on the obtained information and investigation outcome, it was presumed that torsional stress and flexuous stress generated with guide wire manipulation might have been locally applied to the distal segment of the subject meister 16 guide wire while the distal segment of the guide wire was constrained due to vascular anatomy.Consequently, the guide wire coils were disarranged and the coiled segments of the guide wire were bent.As pushing manipulation was applied while the shaft surface of the guide wire was tightened and fixed by a torque device on the proximal side, the polymer jacket on the shaft was distally gathered.Eventually, tensional stress exceeding the product design limit was locally applied on the proximal shaft surface, causing the polymer jacket to undergo ductile fracture and subsequently torn off.Although it was concluded that this event was not attributed to product quality, it was concluded that the polymer jacket of the returned device was too severely damaged to rule out possibility that some polymer fragment could be left in situ.Capa: 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 the manipulation.While paying much attention to possible complications, carefully withdraw the whole system.- when torquing the guide wire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720 degrees) in the same direction.- always advance and withdraw the guide wire slowly.- 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.[precautions].- do not tighten the torque device excessively to the guide wire.Loosen the torque device before moving its position over the guide wire.Otherwise the guide wire may be damaged.[malfunction and adverse effects] - damage - kink - bend.

• 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: yukimi nagumo ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 23663690
• Report Number: 3003775027-2025-00245
• Device Sequence Number: 16021195
• Product Code: DQX
• UDI-Device Identifier: 04547327108317
• UDI-Public: (01)04547327108317(17)280331(10)250423A68A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2025

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-180-16ST
• Device Lot Number: 250423A68A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/26/2025
• 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: Disability
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG