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

Catalog Number	SRD6109
Medical Device Problem Codes	Crack (1135); Degraded (1153); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the operator performed carotid super-selection via the radial artery, choosing a 5fr tempo aqua and preoperatively prepared to flush the first catheter.Its recurve/bend occurred a jet of water.The first device had a leak.The second 5f tempo aqua catheter had an obvious break/leak as well.The case was completed with a third catheter.The devices were not used in the patient.There was no reported injury.There was no damage noted to the packaging of the devices.The devices will not be returned for evaluation as multiple attempts were made without success.
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.
Event or Problem Description
As reported, the operator performed carotid super-selection via the radial artery, choosing a 5fr tempo aqua and preoperatively prepared to flush the first catheter.Its recurve/bend occurred a jet of water.The first device had a leak.The second 5f tempo aqua catheter had an obvious break/leak as well.The case was completed with a third catheter.The devices were not used in the patient.There was no reported injury.There was no damage noted to the packaging of the devices.The devices will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the operator performed carotid super-selection via the radial artery, choosing a 5fr tempo aqua and preoperatively prepared to flush the first catheter.Its recurve/bend occurred a jet of water.The first device had a leak.The second 5f tempo aqua catheter had an obvious break/leak as well.The case was completed with a third catheter.The devices were not used in the patient.There was no reported injury.There was no damage noted to the packaging of the devices.A non-sterile catheter ¿catheter 5f tempo aqua 125cm hydrophilic coating¿ was received for analysis.During visual analysis, a cracked condition was seen approximately 6 and 10 cm from the distal tip.Additionally, several kinks on the shaft were seen approximately 23, 55, and 91 cm from the distal tip.No other outstanding details were observed.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Functional analysis was performed and a leak originating from the crack was seen while flushing the device.The damaged area was inspected with a vision system confirming the cracked condition.The cracked area on hub presented evidence fatigue striations.Fatigue striations found on the hub material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to the cracked.Thermogravimetric analysis was performed and results suggest the affected devices experienced prior degradation or lower thermal stability due to heat exposure.The complaint reported by the customer as ¿catheter (body/shaft) ~leakage¿ and ¿catheter (body/shaft) ~ cracked¿ and ¿catheter (body/shaft) ~ degradation¿ was confirmed for both devices.Cracks were seen on the body of the catheters that promoted leakage while the devices were flushed with saline.The cracks were likely caused by environmental degradation (uv radiation, thermal stress, or chemical agents) rather than mechanical stress.The exact cause of the degradation could not be conclusively determined during the analysis.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 and product analysis, the cause of the degradation could not be determined; however, it is potentially related to the manufacturing process of the unit.Therefore, an investigation has been initiated to further review the potential causes.No further action will be taken at this time.
Event or Problem Description
As reported, the operator performed carotid super-selection via the radial artery, choosing a 5fr tempo aqua and preoperatively prepared to flush the first catheter.Its recurve/bend occurred a jet of water.The first device had a leak.The second 5f tempo aqua catheter had an obvious break/leak as well.The case was completed with a third catheter.The devices were not used in the patient.There was no reported injury.There was no damage noted to the packaging of the devices.The devices will be returned for evaluation.

• Brand Name: ENDO DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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 ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 21025536
• Report Number: 9616099-2024-00600
• Device Sequence Number: 20915357
• 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,Followup
• Report Date (Section B): 03/05/2025

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?: Device Returned to Manufacturer
• 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: 01/02/2025; 02/20/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/27/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown