MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. MINAMO; PTCA Guide Wire

Model Number	AH14R026S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an asahi minamo guide wire was used for a percutaneous coronary intervention (pci) to treat an unspecified lesion in the coronary artery.The minamo guide wire was unraveled in the patient body.The physician tried to advance an ivus catheter over the minamo guide wire, but the ivus catheter got stuck.When the minamo guide wire was pulled out of the patient body, it was broken.It was informed that there was no adverse patient effect associated with this event and the patient was discharged.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).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 minamo guide wire was returned for investigation with guide wire tip missing.The outer coil of minamo guide wire was stretched for approximately 320mm from a point approximately 5mm distal to the distal mid solder (set at 25mm from the tip for the purpose of fixing the outer coil onto the inner coil) and then fractured.The inner coil was deformed in three dimensions and stretched for approximately 50mm from the distal mid solder and then fractured.Microscopic observation found that the fracture end of the outer coil was necked, suggesting that the outer coil became fractured due to tensile stress.The core wire was fractured at approximately 25mm distal to the distal mid solder.Microscopic observation of the fracture end of the core wire found dimples on the surface.Microscopic observation found that the fracture end of the inner coil was necked, suggesting that the inner coil became fractured due to tensile stress.Investigation of the returned guide wire suggested that the approximately 1mm of the outer coil, the inner coil and the core wire were detached together with the distal ball tip.Lot history review revealed no anomaly relating to the reported case.No other similar product experience report was received from this lot.Based on the obtained information and the investigation outcome, it was presumed that bending stress might have been locally applied on the coil segment of the minamo guide wire during removal of the ivus catheter with a relatively short guide wire lumen, due to the anatomical condition and the flexibility of the guide wire tip.Consequently, the coil segment of the minamo guide wire was deformed.The bending stress increased resistance between the minamo guide wire and the ivus catheter.Furthermore, tensile stress generated with catheter removal might have been applied on the coil segment of minamo guide wire.Consequently, the minamo guide wire was pulled back proximally and was deformed in three dimensions, causing the wire and the ivus catheter to get stuck to each other.As tensile stress was further applied on the tip of the minamo guide wire during removal of the wire from the ivus catheter, the outer coil, the inner coil and the core wire were fractured.It was concluded that the reported event was not attributed to the product quality.As the detached guide wire tip was not returned, it was unable to completely rule out the potentiality that any guide wire fragment might be left in the patient anatomy.Capa: no capa will be taken.The instructions for use (ifu) states: "[warnings]" 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; otherwise, the guide wire may be damaged and/or trauma may occur.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.Never push, auger, withdraw, or torque this guide wire that meets resistance.Torquing or pushing this guide wire against resistance may cause damage and/or tip separation of this guide wire or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire.If the prolapse of the guide wire tip is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guide wire may occur.Determine the cause of resistance under fluoroscopy and take any necessary remedial action.If resistance is felt due to spasm, bending of the guide wire, or due to trap while operating this guide wire in the blood vessel or removing it, do not torque and/or pull the guide wire itself.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel.If resistance is felt between this guide wire and the other interventional devices while operating this guide wire in the blood vessel, avoid applying excessive force.When abnormal resistance is felt, remove the entire system from the patient's body and determine the cause.Otherwise, the guide wire may break or be damaged and may cause injury to the blood vessel or leave fragments inside the vessel."[malfunction and adverse effects]" kink of the guide wire separation of the guide wire.

• Brand Name: MINAMO
• Common Device Name: PTCA 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: kumiko ooka ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 50942444
• Report Number: 3003775027-2026-00196
• Device Sequence Number: 9498725
• Product Code: DQX
• UDI-Device Identifier: 04547327130745
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: AH14R026S
• Device Lot Number: 260302A211
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• 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