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

Catalog Number	AP14R324P
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.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, findings of lot history record review, and referring to known similar events, it was presumed that stress generated with wire manipulation in attempts to cross the calcified lesion had likely contributed to the reported separation of the core.The applied stress would localize and therefore exceed the product design limit when the wire tip was being caught and restricted its movement likely by the calcified lesion.It was concluded that this event was not attributed to product quality.The subject guide wire is polymer jacketed; therefore, when the polymer jacket torn off in the patient, a possibility could not be completely rule out that some fragment(s) might be left in the vasculature.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.
Event or Problem Description
It was reported that two separate procedures were performed to treat low to moderate calcium and subtotaled lesions in the superficial femoral artery, accessing through pedal or common femoral artery.An asahi gladius mongo es guide wire was used in each procedure when it became apart at the distal end of the wire.The physician managed to remove both wires intact, that were held together somehow, and finished case intervention without a problem.The patient is ok and both cases completed successfully.No other information given and product not saved.Two guide wires are reported under 3003775027-2021-00069 and 3003775027-2021-00070 respectively.

• Brand Name: GLADIUS MONGO 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
• MDR Report Key: 11625731
• Report Number: 3003775027-2021-00070
• Device Sequence Number: 3866276
• Product Code: DQX
• UDI-Device Identifier: 04547327123754
• UDI-Public: (01)04547327123754(17)230331(10)200428A031
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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: 03/31/2023
• Device Catalogue Number: AP14R324P
• Device Lot Number: 200428A031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other