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

Catalog Number	502455
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the packaging of a.035 fixed-core j-curve 3mm x 260cm emerald guidewire was damaged.There was a ¿broken hole¿ in the back of an inner pouch packaging.The inner package was not opened and not re-shelved.There were no reports of patient injury.The device was not used in the patient.The condition was noticed before opening the package.The device was stored normally.The product was not damaged.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35265471 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.
Additional Manufacturer Narrative
As reported, the packaging of an.035 fixed-core j-curve 3mm x 260cm emerald guidewire was damaged.There was a ¿broken hole¿ in the back of an inner pouch packaging.The inner package was not opened and not re-shelved.There were no reports of patient injury.The device was not used in the patient.The condition was noticed before opening the package.The device was stored normally.One non-sterile units of product ¿dgw.035 fc j3mm 260cm tef¿ was received coiled inside its original pouch.Visual inspection revealed a torn condition on the tyvek portion of the packaging (back of the inner pouch).A product history record (phr) review of lot 35265471 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 ¿packaging/pouch/box-frayed/split/torn¿ was confirmed.A torn condition was found on the tyvek.Storage and/or handling factors 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ 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.

• Brand Name: EMERALD
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 17450895
• Report Number: 9681477-2023-00121
• Device Sequence Number: 7288929
• Product Code: DQX
• UDI-Device Identifier: 10705032055031
• UDI-Public: (01)10705032055031(17)250831(10)35265471
• 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
• Report Date (Section B): 09/14/2023

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: 08/31/2025
• Device Catalogue Number: 502455
• Device Lot Number: 35265471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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