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

Catalog Number	502521
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the.035 j-curve diagnostic guidewire device was opened.The doctor prepares to pass the guide through the introducer when he observes a foreign body coming out of the guidewire.The reason for which it is not possible to pass the guide, we proceed to make the change of the input in the room to be used.The packaging of the device was damaged.The sterility of the device was compromised prior to opening.There was no reported injury to the patient.There was no difficulty removing the wire from the packaging.Extra force was not needed to remove the device.The device will not be returned.
Additional Manufacturer Narrative
As reported, the.035 j-curve diagnostic guidewire device was opened.The doctor prepared to pass the guide through the introducer when a foreign body was observed coming out of the guidewire.The reason for which it is not possible to pass the guide, we proceed to make the change of the input in the room to be used.The packaging of the device was damaged.The sterility of the device was compromised prior to opening.There was no reported injury to the patient.There was no difficulty removing the wire from the packaging.Extra force was not needed to remove the device.Requests for additional information/clarification were not provided.The device was not returned for analysis.A product history record (phr) review of lot 35268060 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 the reported ¿guidewire- foreign material¿ and ¿package- compromised sterility¿ could not be confirmed or further clarified, nor a definitive cause for the event established.The cordis diagnostic j wire does not have a lumen.According to the instructions for use, which is not intended as a mitigation of risk, ¿do not use the if the product if the package is open or damaged.Do not withdraw a ptfe coated wire through a metal-cannula needle.Withdrawal may damage the guidewire coating.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¿.Review of the available information suggests that procedural and or handling factors may have contributed to the reported event.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 US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford ; EI ; 7863138372
• MDR Report Key: 17126346
• Report Number: 9681477-2023-00114
• Device Sequence Number: 15312062
• Product Code: DQX
• UDI-Device Identifier: 10705032055116
• UDI-Public: (01)10705032055116(17)251231(10)35268060
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K864058
• 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
• Report Date (Section B): 06/14/2023

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
• Device Catalogue Number: 502521
• Device Lot Number: 35268060
• 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: Not provided
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2023
• 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 INTRODUCER
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native