MAUDE Adverse Event Report: CORDIS CORPORATION EMERALD; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	502521
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, two standard.035 x 150cm j tip emerald diagnostic guidewires were found to have fractures proximal to the j tip when removing from the catheter.There was no harm to the patient.Additional information was requested but not provided.The devices will not be returned for evaluation.
Additional Manufacturer Narrative
This report is related to report number # 9681477 2023 00108.A product history review is expected but not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d2, g1, g3, g6, h1, h2, and h6.This report is related to medwatch report # reported by the initial reporter.As reported, two standard.035 x 150cm j tip emerald diagnostic guidewires were found to have fractures proximal to the j tip when removing from the catheter.There was no harm to the patient.The products were not returned for analysis however, it was reported both affected devices share the same lot number.A product history record (phr) review of lot 35263581 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 devices or images for analysis, the reported customer event ¿guidewire-fractured¿ could not be confirmed for either device.Handling factors such as manipulating the wire 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, ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter and guidewire.When the guidewire is in a vessel, do not advance the movable core if the tip is in a curved shape.Never twist or force the core because excessive force may cause it to penetrate the coil and damage the vessel.¿ 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
As reported, two standard.035 x 150cm j tip emerald diagnostic guidewires were found to have fractures proximal to the j tip when removing from the catheter.There was no harm to the patient.Additional information was requested but not provided.The devices will not be returned for evaluation.

• Brand Name: EMERALD
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 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: 16896380
• Report Number: 9681477-2023-00109
• Device Sequence Number: 12297088
• Product Code: MGB
• UDI-Device Identifier: 10705032055116
• UDI-Public: (01)10705032055116(17)240831(10)35263581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K864058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023
• 2 Devices were Involved in the Event: 1 2

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: 08/31/2024
• Device Catalogue Number: 502521
• Device Lot Number: 35263581
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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 Sex: Unknown