MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CROSSLEAD; PERIPHERAL GUIDE WIRE

Catalog Number	CLN03530A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percutaneous peripheral intervention was performed to treat a mildly calcified lesion in the unspecified lesion in the severely tortuous limb artery.The microcatheter was navigated over the bifurcation and parked in the iliac artery.The crosslead guide wire was inserted into the navicross support catheter.After two minutes of manipulation the wire got stuck.The whole system needed to be removed from the patient.No patient complications associated with this event.
Additional Manufacturer Narrative
Manufacturing site: (b)(4), registration number: (b)(4).When the affected devices were returned to the manufacturer, reportable damage (possible retention of device fragments in the patient's vasculature) was recognized for the first time; therefore, the manufacturer's awareness date is considered the date the devices were returned.The returned crosslead had its polymer jacket peeled off to expose the underlying coil at approximately 85 -91mm from the tip.At approximately 115mm and 145mm from the tip, winding of the coil was loosened due to accumulated torsion.Damage such as kink or deformation that would contribute to fusing of the devices was not confirmed on the returned crosslead.Microscopic observation of the peeled polymer jacket was performed.On the proximal side of the torn end of the polymer jacket, the polymer jacket was pleated due to stretching for approximately 6mm.On the distal side, the torn polymer jacket was folded inside out for approximately 8mm towards the tip.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 investigation outcome, it was presumed that torsion generated with wire manipulation had most likely contributed to the reported fusing of the guide wire and support catheter.Due to tortuous anatomy, the applied stress would localize and therefore exceeded the product design limit, disarrange the coil, and increase frictional resistance of the wire surface.When the guide wire was removed, the polymer-jacked surface was scraped to peel the polymer jacket off.It was concluded that this event was not attributed to product quality.Although no adverse patient effects occurred, it was unable to completely rule out a possibility that fragmented polymer jacket might be left in the patient because of the severity of damage.No capa will be taken.Instructions for use (ifu) states: [warnings] - 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°) in the same direction.[malfunction and adverse effects] - coming off of coating.

• Brand Name: CROSSLEAD
• Common Device Name: 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: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 16244783
• Report Number: 3003775027-2023-00006
• Device Sequence Number: 12413563
• Product Code: DQX
• UDI-Device Identifier: 04547327140195
• UDI-Public: (01)04547327140195(17)250831(10)220831A021
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K213315
• 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): 01/26/2023

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: 08/31/2025
• Device Catalogue Number: CLN03530A
• Device Lot Number: 220831A021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• 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: Other
• Patient Age: 82 YR
• Patient Sex: Female