MAUDE Adverse Event Report: CORDIS CORPORATION EMERALD; WIRE, GUIDE, CATHETER

Catalog Number	502570
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the inner wire of a.038 3mm x 150cm ptfe-coated j-curve tip moveable core tef emerald guidewire stuck through the outer wire.There were no reports of patient injury.The guidewire was found in the reported condition as it was removed from package.The device will be returned for evaluation.
Additional Manufacturer Narrative
The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the inner wire of a.038 3mm x 150cm ptfe-coated j-curve tip moveable core tef emerald guidewire stuck through the outer wire.There were no reports of patient injury.The guidewire was found in the reported condition as it was removed from package.A non-sterile ¿dgw.038 mc j3mm 150cm tef¿ was received for evaluation.During visual inspection, a separation of the coil wire, which exposed the core wire was noted.A high magnification analysis of the coil wire separation was performed and revealed the separation was present along the coil wire path leading to the exposure the core wire.No obvious indication of manufacturing defect was appreciated while observing the affected areas under high magnification.A product history record (phr) review of lot 35265264 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by the customer as ¿guidewire-exposed braidwire/corewire¿ was confirmed.The exact cause of the reported event cannot be conclusively determined during the analysis.Handling factors such as excessive twisting or force while manipulating the guidewire 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 available information 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.
Additional Manufacturer Narrative
-after further review of additional information received the following sections have been updated accordingly: d2, g1, g3, g6, h1, h2, h3, h6, and h10.-the product history review is expected but has not been completed.-this device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.-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: -a review of the manufacturing documentation associated with lot 35265264 presented no issues during the manufacturing process that can be related to the reported event.-this device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.-additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: EMERALD
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 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 ; 7863138372
• MDR Report Key: 17052618
• Report Number: 9681477-2023-00113
• Device Sequence Number: 15213571
• Product Code: DQX
• UDI-Device Identifier: 10705032055444
• UDI-Public: (01)10705032055444(17)250731(10)35265264
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2023

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: 07/31/2025
• Device Catalogue Number: 502570
• Device Lot Number: 35265264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 07/19/2023; 09/20/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/07/2023; 08/11/2023; 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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: UNKNOWN.
• Patient Sex: Unknown