MAUDE Adverse Event Report: CORDIS CORPORATION ATW STEERABLE GUIDEWIRES; WIRE, GUIDE, CATHETER

Catalog Number	595X014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was a fracture of the 0.014-inch x 300cm atw straight tip floppy marker guidewire, with loss of its covering, and apparent lodging at the extravascular level."recovery of the same is not achieved".There were no reports of patient injury.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, there was a fracture of the 0.014-inch x 300cm atw straight tip floppy marker guidewire, with loss of its covering, and apparent lodging at the extravascular level."recovery of the same is not achieved".There were no reports of patient injury.Additional information was requested but not provided.The device was not returned for evaluation.Without the return of the device or images for analysis, the reported customer event ¿distal tip-fractured¿ could not be confirmed.Procedural or handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿guidewire manipulation/torquing should always be performed under fluoroscopic guidance.Never push, auger, withdraw, or torque a guidewire that meets resistance.First, using fluoroscopy, determine the cause of resistance and take any necessary remedial action.Torquing or pushing a guidewire against resistance may cause guidewire damage, and/or guidewire tip separation, or direct damage to the vessel.Resistance may be felt and/or observed (via fluoroscopy) by noting any buckling of the guidewire tip.If guidewire tip prolapse is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guidewire may occur.If any resistance is felt, e.G., due to vessel spasm, bent guidewire, or guidewire entrapment, while manipulating or removing the guidewire in the blood vessel: stop the procedure.Do not move or torque the guidewire.Using fluoroscopy, first determine the cause of the resistance, then take appropriate remedial action.If the guidewire is moved excessively, it may break or become damaged.This may cause blood vessel injury or result in fragments being left inside the vessel.Should torque control/tip response be compromised during use, confirm tip integrity using fluoroscopy.Loss of torque control may be due to core wire fracture.Under fluoroscopic guidance, advance the balloon catheter to the distal end of the guidewire and remove the balloon catheter/ guidewire system as a unit.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: ATW STEERABLE GUIDEWIRES
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 avenue; miami lakes
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford
• MDR Report Key: 20290543
• Report Number: 1016427-2024-00031
• Device Sequence Number: 12562647
• Product Code: DQX
• UDI-Device Identifier: 10705032056687
• UDI-Public: (01)10705032056687(17)250430(10)35268143
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 595X014
• Device Lot Number: 35268143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic