MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GLADIUS MONGO 14 ES; PTCA GUIDE WIRE

Catalog Number	AP14R324S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).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 and the investigation outcome, it was presumed that stress generated with wire manipulation might have been locally accumulated on the distal segment of the guide wire while the tip was being caught by the lesion.Consequently, the stress exceeded the product design limit, separating the wire tip.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 gladius mongo 14 es guide wire was used to cross a 100% occluded lesion in the moderately calcified proximal to mid segment of the anterior tibial artery.When the gladius mongo 14 es guide wire was advanced to the distal popliteal artery, the guide wire went into the subintimal space in the proximal occluded lesion.While attempts were being made to navigate back the guide wire to the true lumen by withdrawing the guide wire from the concomitant catheter, the distal segment of the guide wire broke off.The intravascular ultrasound (ivus) image revealed that the wire fragment was left in the subintimal space the physician decided that the fragment could not be snared out and therefore would be left in situ.Laser atherectomy and percutaneous transluminal angioplasty (pta) were performed, and the procedure was successfully completed with reestablished blood flow.It was informed that there were no adverse patient effects associated with the event, and the patient was discharged after the procedure.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).The reported gladius mongo 14 es was returned for investigation.Multiple bends were found on the coil segment of the returned gladius mongo 14 es.Polymer jacket of the guide wire was found elongated and torn for approximately 11mm from approximately 2mm distal to the proximal solder (set at 30mm from the wire tip).The core wire was exposed for approximately 3mm proximal to the torn end of the polymer jacket.The outer coil was found elongated, fractured, and exposed for approximately 20mm from the torn end of the polymer jacket.When the polymer jacket was removed for observation of the coil and core fracture ends, the core wire was found fractured at approximately 15mm distal to the proximal solder.The outer coil was found elongated and fractured at approximately 63mm from the tip.Observation by microscope and scanning electron microscope (sem) of the core wire found circumferential cracks on the core wire and dimples on a relatively flat fracture surface, indicating that bending stress and tensional stress had contributed to the core wire fracture.Observation by microscope and sem of the outer coil fracture end found that the coil strand was twisted, indicating that the outer coil fracture was attributed to torsion generated most likely when the outer coil was pulled and straightened.Measurement of the returned gladius mongo 14 es suggested that the core wire was fractured at approximately 15mm from the wire tip and the outer coil was detached together with the polymer jacket at approximately 24mm from the wire tip.The distal segment of the guide wire was detached together with the inner coil.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 provided information and the investigation outcome, it was presumed that bending stress generated with guide wire rotation while the distal segment of the gladius mongo 14 es had been caught by the calcified lesion might have been locally accumulated on the distal segment of the guide wire.Consequently, the core wire was fractured.Further applied tensile stress generated with removal caused the outer coil to be elongated and fractured.Eventually, the distal segment of the guide wire was detached.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.

• Brand Name: GLADIUS MONGO 14 ES
• 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: 19048084
• Report Number: 3003775027-2024-00043
• Device Sequence Number: 7355336
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)261130(10)231130A291
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K180784
• 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): 05/01/2024

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 Catalogue Number: AP14R324S
• Device Lot Number: 231130A291
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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: Disability
• Patient Sex: Unknown