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

Catalog Number	502571
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during the procedure,.035 emerald j3 diagnostic guide catheter was inserted in the introducer.While doctor was trying to move the device inside the vessel, he/she realized the tip of the device detached.He/she removed the guidewire and substituted with a new one.There was no reported injury to the patient.Additional information and device return was requested; however, neither were not obtained after multiple attempts made.
Additional Manufacturer Narrative
As reported, during the procedure,.035 emerald j3 diagnostic guide catheter was inserted in the introducer.While doctor was trying to move the device inside the vessel, he/she realized the tip of the device detached.He/she removed the guidewire and substituted with a new one.There was no reported injury to the patient.Additional information and device return was requested; however, neither were obtained after multiple attempts made.The reported ¿distal tip fractured-separated¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Factors such as vessel anatomy, user handling, and concomitant devices could be a contributing factor additional force and manipulation of the catheter may have also been a contributing factor the reported event.All catheters require torquing, which is a dynamic process once it enters the patient due to external factors such as temperature, time of exposure in body, individual patient anatomical structures, storage conditions, and operator technique in torquing and manipulating the catheter.If a catheter does not move as expected, the operator is trained to stop and investigate the cause before continuing to avoid further damage to the catheter, such as a separation.The information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h1, h2, h3, and h11.As reported, during the procedure,.035 emerald j3 diagnostic guide catheter was inserted in the introducer.While doctor was trying to move the device inside the vessel, he/she realized the tip of the device detached.He/she removed the guidewire and substituted with a new one.The procedure was completed using another guide catheter.The procedure did not cause any injury to the patient.The device was prepared according to the specified instructions for use (ifu).There was no apparent damage to the device prior to use.There was no resistance or friction while advancing it through the vessel.Additionally, no unusual force was needed to advance or withdraw the catheter from the patient.The lesion was not calcified, and there was no vessel tortuosity.An unknown guidewire was used, and there was no resistance while advancing over the guidewire.The reported ¿distal tip fractured separated¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Factors such as vessel anatomy, user handling, and concomitant devices could be a contributing factor additional force and manipulation of the catheter may have also been a contributing factor the reported event.All catheters require torquing, which is a dynamic process once it enters the patient due to external factors such as temperature, time of exposure in body, individual patient anatomical structures, storage conditions, and operator technique in torquing and manipulating the catheter.If a catheter does not move as expected, the operator is trained to stop and investigate the cause before continuing to avoid further damage to the catheter, such as a separation.The information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Event or Problem Description
As reported, during the procedure,.035 emerald j3 diagnostic guide catheter was inserted in the introducer.While doctor was trying to move the device inside the vessel, he/she realized the tip of the device detached.He/she removed the guidewire and substituted with a new one.The procedure was completed using another guide catheter.The procedure did not cause any injury to the patient.The device was prepared according to the specified instructions for use (ifu).There was no apparent damage to the device prior to use.There was no resistance or friction while advancing it through the vessel.Additionally, no unusual force was needed to advance or withdraw the catheter from the patient.The lesion was not calcified, and there was no vessel tortuosity.An unknown guidewire was used, and there was no resistance while advancing over the guidewire.The device will not be returned for evaluation as multiple attempts were made without success.

• Brand Name: EMERALD
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60 avenue 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: 20385142
• Report Number: 1016427-2024-00036
• Device Sequence Number: 6567044
• Product Code: DQX
• UDI-Device Identifier: 10705032055475
• UDI-Public: (01)10705032055475(17)260731(10)35269624
• 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): 10/21/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 502571
• Device Lot Number: 35269624
• 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
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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: NEW GUIDEWIRE.
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Sex: Unknown