MAUDE Adverse Event Report: CORDIS CORP 6F .072 XB 3.5 100CM; CATHETER, PERCUTANEOUS

Model Number	67205400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the head end of a 6f.072 extra back up 3.5 100cm adroit guiding catheter was broken.The tip of the catheter was frayed.The ¿head end¿ is the distal tip and it could not pass through an unknown 6f cordis radial sheath.The catheter was ¿not broken¿ but noticed the malfunction inserting into the patient.An unknown guide catheter was used to complete the procedure.It had no impact on the patient and there was no reported patient injury.The device was used in a percutaneous coronary intervention (pci) of the right coronary artery (rca).There was no calcification, tortuosity, acute angle or bifurcation of the target vessel.There was a stenosis of 80% at the target vessel.There was no calcification, tortuosity, stenosis, acute angle or bifurcation accessing the target vessel.The device was used for treatment of a chronic total occlusion (cto).The device was used with a radial approach with no contralateral approach.The device was stored and prepped per instructions for use (ifu).The user is trained to the device.There was no difficulty experienced in prepping the device.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was not returned for evaluation.
Additional Manufacturer Narrative
As reported, the head end of a 6f.072 extra back up 3.5 100cm adroit guiding catheter was broken.The tip of the catheter was frayed.The ¿head end¿ is the distal tip and it could not pass through an unknown 6f cordis radial sheath.The catheter was ¿not broken¿ but noticed the malfunction inserting into the patient.An unknown guide catheter was used to complete the procedure.It had no impact on the patient and there was no reported patient injury.The device was used in a percutaneous coronary intervention (pci) of the right coronary artery (rca).There was no calcification, tortuosity, acute angle or bifurcation of the target vessel.There was a stenosis of 80% at the target vessel.There was no calcification, tortuosity, stenosis, acute angle or bifurcation accessing the target vessel.The device was used for treatment of a chronic total occlusion (cto).The device was used with a radial approach with no contralateral approach.The device was stored and prepped per instructions for use (ifu).The user is trained to the device.There was no difficulty experienced in prepping the device.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was not returned for evaluation.A product history record (phr) review of lot 18018848 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 or images for analysis, the reported customer event ¿brite tip/distal tip-frayed/split/torn¿ could not be confirmed.Procedural factors such as the difficulty described while attempting to insert the catheter into the sheath, 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, ¿do not use if package is open or damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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.
Additional Manufacturer Narrative
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: g3, g6, h1, h2, h3, h6, and h10 as reported, the head end of a 6f.072 extra back up 3.5 100cm adroit guiding catheter was broken.The tip of the catheter was frayed.The ¿head end¿ is the distal tip and it could not pass through an unknown 6f cordis radial sheath.The catheter was ¿not broken¿ but noticed the malfunction inserting into the patient.An unknown guide catheter was used to complete the procedure.It had no impact on the patient and there was no reported patient injury.The device was used in a percutaneous coronary intervention (pci) of the right coronary artery (rca).There was no calcification, tortuosity, acute angle or bifurcation of the target vessel.There was a stenosis of 80% at the target vessel.There was no calcification, tortuosity, stenosis, acute angle or bifurcation accessing the target vessel.The device was used for treatment of a chronic total occlusion (cto).The device was used with a radial approach with no contralateral approach.The device was stored and prepped per instructions for use (ifu).The user is trained to the device.There was no difficulty experienced in prepping the device.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was not returned for evaluation.A product history record (phr) review of lot 18018848 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 or images for analysis, the reported customer event ¿brite tip/distal tip-frayed/split/torn¿ could not be confirmed.Procedural factors such as the difficulty described while attempting to insert the catheter into the sheath, 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, ¿do not use if package is open or damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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: 6F .072 XB 3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15931948
• Report Number: 9616099-2022-06142
• Device Sequence Number: 6562683
• Product Code: DQY
• UDI-Device Identifier: 20705032065310
• UDI-Public: 20705032065310
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131225
• 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,Followup,Followup
• Report Date (Section B): 01/25/2023

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: 03/31/2024
• Device Model Number: 67205400
• Device Catalogue Number: 67205400
• Device Lot Number: 18018848
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/17/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/06/2023; 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN GUIDING CATHETER
• Patient Sex: Female