MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. PROWATERFLEX; PTCA GUIDE WIRE

Model Number	AGH147000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.Device evaluation could not be performed because the affected device had not been returned yet.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 reviewing the known similar events, it was presumed that stress generated with guide wire manipulation while the subject prowaterflex guide wire was caught due to anatomical and conditions.Consequently, the guide wire was fractured.It was concluded that this event was not attributed to product quality.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.[malfunction and adverse effects]: separation of the guide wire.
Event or Problem Description
It was reported that an asahi prowaterflex guide wire was fractured in the left main trunk (lmt) during a percutaneous coronary intervention (pci) to treat the segment from the lmt to the left anterior descending artery (lad).The wire fragment was left in situ.It was informed that the patient eventually died.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).The reported prowaterflex guide wire was returned for investigation.The returned prowaterlflex guide wire was found three-dimensionally deformed for approximately 30mm from the distal mid solder (set at 25mm from the wire tip to fix the outer coil onto the core wire).The outer coil of the guide wire was found elongated for approximately 45mm from the distal mid solder and fractured.The ball tip was not found at the very distal end of the outer coil.The core wire was coming out of the distal mid solder for approximately 10mm.The outer coil was found disarranged at approximately 10mm and 14mm proximal to the distal mid solder.Observation by microscope and scanning electron microscope (sem) of the core wire found necking of the fracture end and dimples on a relatively flat fracture surface, indicating that tensional stress had contributed to the core wire fracture.Observation by microscope and sem of the outer coil fracture end found a relatively flat fracture surface, indicating that torsion was generated as the coil structure had been straightened by tension.Twisting of the outer coil was also observed at the fracture end.Measurement of the returned prowaterflex guide wire suggested that the core wire was fractured at approximately 15mm from the wire tip and the outer coil was elongated and detached together with the ball tip at approximately 20mm from the wire tip.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 the investigation outcome, it was presumed that tensional stress generated with guide wire manipulation during withdrawal attempts might have been locally accumulated on the distal segment of the subject prowaterflex guide wire while its distal segment had been caught by the deployed stent strut.Consequently, the guide wire was fractured.It was concluded that this event was not attributed to product quality.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.[malfunction and adverse effects] separation of the guide wire.
Event or Problem Description
It was reported that the patient with a 100%-occluded left main trunk (lmt) was in cardiogenic shock when he was brought in the catheterization laboratory.Percutaneous coronary intervention (pci) was performed to treat a 100%-occluded, heavily calcified lesion of 30mm in length in the lmt.An asahi prowaterflex guide wire was used with an unspecified balloon catheter to deploy a 3.5mm-in-diameter resolute onyx stent (medtronic) to successfully re-canalize the lmt.At the end of the procedure, the subject prowaterflex was being removed but slight resistance was met.As the guide wire was continued to be pulled back, the distal segment of the guide wire was found broken off.The deployed stent was immediately crushed in the lmt, resulting in unsuccessful re-canalization.It was informed that the patient eventually died.The physician commented that the subject prowaterflex met resistance probably because the guide wire might have been trapped by a part of the stent strut.As he kept pulling back the guide wire against resistance for removal, the stent went crushed.Consequently, the lmt was completely closed off, preventing the physician from entering any device in the lmt and causing cardiac arrest.Nothing was able to re-canalize the lesion at that point.

• Brand Name: PROWATERFLEX
• 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: yukimi nagumo ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 21569061
• Report Number: 3003775027-2025-00086
• Device Sequence Number: 15561336
• Product Code: DQX
• UDI-Device Identifier: 04547327056311
• UDI-Public: (01)04547327056311(17)270930(10)241010A111
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K163426
• 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): 04/04/2025

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: AGH147000
• Device Lot Number: AGH147000
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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: Death
• Patient Age: 46 YR
• Patient Sex: Male