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

Model Number	AG141002
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that percutaneous coronary intervention to treat a heavily calcified, moderately tortuous, and heavily flexuous lesion in the mid left circumflex artery (lcx).Two units of asahi grand slam guide wires, together with a guidezilla microcatheter (boston scientific) and an unspecified 8fr ebu guiding catheter were used to deploy an unspecified stent system in the heavily calcified lesion but tension and resistance were met.When attempts were made to pull back the stent units for reposition, the stents dislodged from the stent system, causing the two grand slam guide wires to break off and leaving the wire fragments in the lcx.The physician then captured the stents and the wire fragments were stented to complete the procedure.It was informed that there were no adverse patient effects due to the reported event.
Additional Manufacturer Narrative
Manufacturing site: toyoflex cebu corporation, cebu, philippines, registration number: 3016119728.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.Based on the obtained information, lot history review, and referring to known similar events, it was presumed that tension exceeding the product design limit might have been applied on the subject grand slam guide wires during stent reposition attempts while the distal segment of the guide wire had been caught by the stents.Consequently, the guide wire was separated.Although it was concluded that the reported event was not attribute to the product quality, it was concluded that stenting the wire fragments was an additional treatment.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.~ do not perform stent placement using more than one guide wire or wire operation through stent strut.Otherwise, the stent may be damaged or the guide wire may break or break apart.[malfunction and adverse effects] ~ separation of the guide wire.
Additional Manufacturer Narrative
This report is about another unit of grand slam guide wire that had been used and reportedly fractured, whose fragment left in situ during the same procedure with the grand slam guide wire that was reported under 51760-51865 2025-00061.As the initial report failed to describe that, this report is submitted.In addition, there was an error in d2 common device name; the initial report incorrectly indicated the name as "grand slam" although it should be "ptca guide wire." therefore, it is corrected in this report.

• Brand Name: GRAND SLAM
• 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: 21320013
• Report Number: 3003775027-2025-00058
• Device Sequence Number: 8620985
• Product Code: DQX
• UDI-Device Identifier: 04547327055833
• UDI-Public: (01)04547327055833(17)270531(10)240601A03F
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022762
• 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): 02/09/2025

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: AG141002
• Device Lot Number: 240601A03F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Disability
• Patient Sex: Unknown