MAUDE Adverse Event Report: Cordis US Corp. SV018; Wire, Guide, Catheter

Catalog Number	503558X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, there was damage to two.018 300cm sv-5 straight tip guidewires.The guidewire was fractured at the distal tip, and the damage was observed after use inside the patient.The guidewires did not separate into two pieces.Both guidewires fractured but remained intact without separated pieces.The fractures resulted in the guidewires failing to provide the support needed to cross the lesion.The guidewire was replaced with a non-cordis.035 guidewire.There were no reported injuries to the patient.The devices were stored according to the instructions for use (ifu).No damage to the device packaging or guidewire hoops was reported prior to opening.The wires were not removed from their dispensers by the distal floppy end; they were removed from the proximal portion at the catheter hub.The devices will not be returned for evaluation.
Additional Manufacturer Narrative
As reported, there was damage to two.018 300cm sv-5 straight tip guidewires.The guidewire was fractured at the distal tip, and the damage was observed after use inside the patient.The guidewires did not separate into two pieces.Both guidewires fractured but remained intact without separated pieces.The fractures resulted in the guidewires failing to provide the support needed to cross the lesion.The guidewire was replaced with a non-cordis.035 guidewire.There were no reported injuries to the patient.The devices were stored according to the instructions for use (ifu).No damage to the device packaging or guidewire hoops was reported prior to opening.The wires were not removed from their dispensers by the distal floppy end; they were removed from the proximal portion at the catheter hub.The devices will not be returned for evaluation.The device associated with (b)(4) was not returned for product analysis.A product history review (phr) of lot 35273146 was completed for (b)(4) the completed phr do not suggest that the failure experienced by the customer was related to the manufacturing process.The reported ¿guidewire - fractured¿ could not be substantiated for either device because the devices were not returned for product evaluation.The exact cause of the event cannot be determined based on the available complaint information.No evidence of use inconsistent with the product labeling or of a labeling-related contribution to the reported event was identified.Based on the available complaint information and the completed phrs, no evidence was identified to suggest that the failure experienced by the customer was related to the manufacturing process.Therefore, no further action will be taken at this time.

• 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 ; +011(786)3138372
• MDR Report Key: 50778872
• Report Number: 1016427-2026-00085
• Device Sequence Number: 9939571
• Product Code: DQX
• UDI-Device Identifier: 10705032056069
• UDI-Public: (01)10705032056069(17)270531(10)35273146
• 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): N
• 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): 09/28/2026

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: 35273146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Male