MAUDE Adverse Event Report: CORDIS US CORP. SV018; WIRE, GUIDE, CATHETER

Catalog Number	503558X
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
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, during use of the three.018 sv short 300cm sv guidewires, that the distal tip portion of the guidewire was torn and detached.There was no reported injury to the patient.The devices will be returned for evaluation.

• Brand Name: SV018
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford ; 7863138372
• MDR Report Key: 25762070
• Report Number: 1016427-2026-00059
• Device Sequence Number: 9898705
• Product Code: DQX
• UDI-Device Identifier: 10705032056069
• UDI-Public: (01)10705032056069(17)270131(10)35272659
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K930091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/21/2026

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
• Device Catalogue Number: 503558X
• Device Lot Number: 35272659
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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: Life Threatening; Other
• Patient Sex: Unknown