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

Model Number	503558X
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35264711 presented no issues during the manufacturing process that could be related to the event reported.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 0.018" 300cm straight tip (st) sv peripheral steerable guidewire (pgw) broke during use, leaving a fragment impacted in the anterior tibial artery.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, the 0.018" 300cm straight tip (st) sv peripheral steerable guidewire (pgw) broke during use, leaving a fragment impacted in the anterior tibial artery.The product was not returned for analysis.A product history record (phr) review of lot 35264711 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿guidewire-fractured-separated¿ could not be confirmed.Handling factors such as removing the wire from the dispenser by the distal floppy end or torquing the device against resistance 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, ¿never advance, withdraw or auger the guidewire against resistance without first determining the cause of resistance under fluoroscopy.Torquing the guidewire against resistance may cause damage and/or fracture which may result in separation of the distal tip.Do not pull the distal tip to remove guidewire from dispenser as it may damage the tip.Tip fractures have been reported in procedures involving total occlusions, highly tortuous vasculature, and small side branches.¿ based on the information available and the phr review, 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.
Event or Problem Description
Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was expected to be returned for evaluation; however, no product return information was provided.

• Brand Name: SV018
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford, ireland ; 7863138372
• MDR Report Key: 17190661
• Report Number: 9681477-2023-00115
• Device Sequence Number: 7338345
• Product Code: DQX
• UDI-Device Identifier: 10705032056069
• UDI-Public: (01)10705032056069(17)240731(10)35264711
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 07/31/2024
• Device Model Number: 503558X
• Device Catalogue Number: 503558X
• Device Lot Number: 35264711
• Was Device Available for Evaluation?: Yes
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown