MAUDE Adverse Event Report: CORDIS CORPORATION ENDO DIAGNOSTIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	SRD6109
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of 5f 125cm tempo aqua contrast catheter was found cracked when opening the package.The device cracked but did not separate into two separate pieces.The procedure was completed by changing to another sim2 catheter.There was no reported injury to the patient.There was no damage to the packaging of the device, and the product was stored without any damage in the lab.The device was prepped per the instructions for use (ifu), and no difficulty was experienced during the prep.The access site was the radial artery, and the intended procedure was for carotid artery stenosis.There was no vessel tortuosity.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the tip of 5f 125cm tempo aqua contrast catheter was found to be cracked at the distal end of the body/shaft when opening the package.The device cracked but did not separate into two separate pieces.The procedure was completed by changing to another sim2 catheter.There was no reported injury to the patient.There was no damage to the packaging of the device, and the product was stored without any damage in the lab.The device was prepped per the instructions for use (ifu), and no difficulty was experienced during the prep.The access site was the radial artery, and the intended procedure was for carotid artery stenosis.There was no vessel tortuosity.The device was not returned for evaluation.One photo was submitted for review, and it revealed a cracked condition on the body of the catheter.No other anomalies or outstanding details could be observed in the image.The event ¿catheter (body/shaft) ¿ cracked¿ was confirmed since a cracked condition was noted on the body/shaft.However, the root cause cannot be determined because the device was not returned for evaluation.It¿s possible that storage or handling factors may have caused the crack.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 available information, 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.
Event or Problem Description
As reported, the tip of 5f 125cm tempo aqua contrast catheter was found to be cracked at the distal end of the body/shaft when opening the package.The device cracked but did not separate into two separate pieces.The procedure was completed by changing to another sim2 catheter.There was no reported injury to the patient.There was no damage to the packaging of the device, and the product was stored without any damage in the lab.The device was prepped per the instructions for use (ifu), and no difficulty was experienced during the prep.The access site was the radial artery, and the intended procedure was for carotid artery stenosis.There was no vessel tortuosity.The device will not be returned for evaluation as multiple attempts were made without success.

• Brand Name: ENDO DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 21181091
• Report Number: 9616099-2025-00093
• Device Sequence Number: 8546532
• Product Code: DQO
• UDI-Device Identifier: 10705032049795
• UDI-Public: (01)10705032049795(17)251031(10)18163127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000579
• 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): 02/07/2025

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: 10/31/2025
• Device Catalogue Number: SRD6109
• Device Lot Number: 18163127
• 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: 01/19/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• 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: 125CM SIM2 CATHETER
• Patient Sex: Unknown