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

Model Number	AG141302
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: toyoflex cebu corporation, cebu, philippines, registration number: (b)(4).The reported grand slam guide wire was returned with its fragment.The proximal side of the returned grand slam guide wire was found kinked at approximately 3mm proximal to the mid solder (located at 25mm from the wire tip to fix the outer coil onto the core wire).The outer coil was elongated distally from the mid solder for approximately 50mm and fractured.The core wire was found fractured at approximately 7mm distal to the mid solder.Microscopic observation of the proximal side of the grand slam guide wire found that the fracture end of the outer coil had 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.The fracture end of the core wire was twisted and its fracture surface was relatively flat, which could be attributed to torsion.Ball tip was found at the very distal end of the fragment of the grand slam guide wire, which was kinked at approximately 5mm from the wire tip.The core wire was found fractured at approximately 18mm proximal to the wire tip, while the outer coil was elongated for approximately 70mm from approximately 5mm proximal to the wire tip.Microscopic observation of the wire fragment found that the fracture end of the core wire was twisted and had a relatively flat fracture surface, which could be attributed to torsion.The fracture end of the outer coil was also twisted and had a relatively flat fracture surface, which could be attributed to torsion.Investigation of the returned grand slam guide wire found that the outer coil was elongated and fractured and the core wire was fractured; however, measurement suggested that the entire guide wire was returned as the length of each of the core wire and outer coil was consistent with the product specification.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 investigation outcome, it was presumed that excessive torsion generated with torquing manipulation might have been locally accumulated on the distal segment of the subject grand slam guide wire while the distal segment of the guide wire was caught in the calcium, causing the core wire to be fractured.As torsion was generated and applied to the guide wire as the coil structure of the outer coil was straightened by tension during withdrawal attempts, the distal segment of the guide wire was completely detached.Although it was concluded that this event was not attributed to product quality, removal of wire fragment with a snare is considered as an additional treatment and therefore an adverse event.It was also concluded that possibility of fragment left in patient anatomy could not be completely eradicated if the same event were to recur.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.When torquing this guide wire inside the blood vessel, do not torque continuously in the same direction.This may cause the guide wire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel.When torquing the guide wire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720 degrees) in the same direction.[malfunction and adverse effects] separation of the guide wire.
Event or Problem Description
It was reported that an asahi grand slam guide wire was used during a percutaneous peripheral intervention (ppi) to treat a heavily calcified lesion in the proximal tibial artery.As the grand slam guide wire was caught by the calcium and fractured, an unspecified snare was used to successfully remove the fragment.It was informed that there were no adverse patient effects.

• 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: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 20554053
• Report Number: 3003775027-2024-00114
• Device Sequence Number: 14231635
• Product Code: DQX
• UDI-Device Identifier: 04547327055857
• UDI-Public: (01)04547327055857(17)270131(10)240203A08F
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: AG141302
• Device Lot Number: 240203A08F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/29/2024
• 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: Required Intervention
• Patient Sex: Unknown