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

Catalog Number	AG141300
Medical Device Problem Codes	Fracture (1260); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an asahi soft guide wire became fractured during a percutaneous coronary intervention (pci) to treat a moderately calcified, moderately tortuous, 90-99% stenosis in the distal right coronary artery (rca).The guide wire was removed and exchange to a second soft.The pci was completed with success.There were no adverse patient effects associated with this event.
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device evaluation could not be performed because the affected device was not returned.Lot history review was performed on each lot and revealed no anomaly relating to the reported event.No other similar product experience report was received from either lot.Both were made by the same manufacturing site.Based on the obtained information, results of lot history review, and referring to known similar events, it was presumed that stress generated with wire manipulation in attempts to cross had likely contributed to fracturing the soft guide wire.It was likely that the tip of soft was caught by the lesion to localize and accumulate the applied stress on the tip.Consequently, the accumulated stress exceeded the product design limit and the tip became fractured.It was concluded that this event was not attributed to product quality.From the given information, it was unable to completely rule out a possibility that the fractured tip might be remaining in the patient.No capa will be taken.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 or breakage of the guide wire.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.The reported soft guide wire was returned for evaluation.The coil pitch was widened to stretch the coil for approximately 5mm distal to the mid solder that was set at 25mm from the tip.Distal to the stretched segment, the guide wire was deformed in a hook.No fracture on the coil or core wire was confirmed on the returned guide wire.Lot history review was performed on each lot and revealed no anomaly relating to the reported event.No other similar product experience report was received from either lot.Both were made by the same manufacturing site.Based on the provided information and investigation outcome, it was presumed that tensile stress generated with wire manipulation in attempts to cross had most likely contributed to widening the coil pitch of the soft guide wire.It was likely that the tip of soft was caught by the lesion to localize and accumulate the applied stress on the tip.Consequently, the accumulated stress exceeded the product design limit and the coil was stretched.When removed, the wire surface was probably rubbed to form a hook.The stretched segment was misidentified as the wire looked fractured under fluoroscopy.It was concluded that this event was not attributed to product quality and unlikely to cause or contribute to patient injury.No capa will be taken.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] ~ breakage of the guide wire.

• Brand Name: SOFT
• 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: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 15547722
• Report Number: 3003775027-2022-00125
• Device Sequence Number: 1995468
• Product Code: DQX
• UDI-Device Identifier: 04547327056229
• UDI-Public: (01)04547327056229(17)250331(10)220404A361
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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 Expiration Date: 03/31/2025
• Device Catalogue Number: AG141300
• Device Lot Number: 220404A361
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2022
• 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 Age: 82 YR
• Patient Sex: Female