MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GLADIUS MG 14 PV ES; PERIPHERAL GUIDE WIRE

Catalog Number PP14R304P

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).When the reported product was returned to the manufacturer, reportable malfunction was recognized for the first time; therefore, g3.Date received by manufacturer is the same as the date in d9.Returned to manufacturer.The reported gladius mg 14 pv es guide wire was returned for evaluation with the concomitant corsair pv microcatheter.The polymer jacket of the returned gladius mg 14 pv es guide wire was found peeled off at approximately 30-45mm from the guide wire tip.Part of the torn polymer fragment remained on the core shaft.Stretching of the polymer jacket was observed proximal to its torn end.The shaft of the concomitant corsair pv microcatheter was found slightly tortuously deformed due to use.A hole was observed at approximately 2mm from the catheter tip, which could be caused by guide wire penetration.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 concluded that the tip of the gladius mg 14 pv es guide wire might have hit the lumen wall of the concomitant corsair pv while the catheter tip had been bent likely due to the anatomical conditions.As a result, the guide wire tip could have gone through the subject catheter tip segment.Consequently, resistance could be increased between the two devices and the polymer jacket of the gladius mg 14 pv es guide wire could be peeled off.It was concluded that this event was not attributed to product quality.Given the severe damage observed on the polymer jacket of the returned guide wire, it was unable to completely rule out a possibility that some polymer jacket fragment(s) might be left 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.~ if resistance is felt between this guide wire and the other interventional devices while operating this guide wire in the blood vessel, avoid applying excessive force.When abnormal resistance is felt, remove the entire system from the patient's body and determine the cause.Otherwise, the guide wire may break or be damaged and may cause injury to the blood vessel or leave fragments inside the vessel.[malfunction and adverse effects] ~ abrasion of the guide wire coating.

Event Description

It was reported that a percutaneous peripheral intervention (ppi) was performed to treat a heavily calcified total occlusion in the below-the-knee area.When an asahi gladius mg 14 pv es guide wire was used with an asahi corsair pv microcatheter, resistance was noted and the device operability became deteriorated.The two devices were then removed as a unit.The intended treatment was successfully completed with another device system.There were no adverse patient effects associated with this event.The patient was reportedly fine without problem after the procedure.

• Brand Name: GLADIUS MG 14 PV ES
• Type of Device: PERIPHERAL 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: 17448370
• MDR Text Key: 320284802
• Report Number: 3003775027-2023-00072
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327124775
• UDI-Public: (01)04547327124775(17)251231(10)230106A691
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PP14R304P
• Device Lot Number: 230106A691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other