MAUDE Adverse Event Report: CORDIS US CORP INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	538421
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 4f 100 cm judkins right (jr4) infiniti diagnostic catheter broke in half during injection.The device separated while hooking up to the injector, occurring in the patient but exterior to the body, allowing it to be simply removed.There was no reported patient injury.The catheter did not become entrapped at any point.The intended procedure was reported to be a left heart catheterization (lhc), which was completed using another infiniti catheter, and no contralateral approach was used.The vessel characteristics at the target site were normal, with no calcification, tortuosity, stenosis, acute angle, or bifurcation noted.The access site was the right renal artery (rra), also without calcification, tortuosity, stenosis, acute angle, or bifurcation.The device was not pulled from the packaging by the hub, nor was it torqued or steered by the hub.No difficulties were encountered in inserting, advancing, or withdrawing the device.The product was stored and handled according to the instructions for use (ifu), and no device damage was noticed prior to opening the package.There was no difficulty removing the device from sterile packaging, and it was prepped per the ifu without difficulty.No procedural cd was available.
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, a 4f 100 cm judkins right (jr4) infiniti diagnostic catheter broke in half during injection.The device separated while hooking up to the injector, occurring in the patient but exterior to the body, allowing it to be simply removed.There was no reported patient injury.The catheter did not become entrapped at any point.The intended procedure was reported to be a left heart catheterization (lhc), which was completed using another infiniti catheter, and no contralateral approach was used.The vessel characteristics at the target site were normal, with no calcification, tortuosity, stenosis, acute angle, or bifurcation noted.The access site was the right renal artery (rra), also without calcification, tortuosity, stenosis, acute angle, or bifurcation.The device was not pulled from the packaging by the hub, nor was it torqued or steered by the hub.No difficulties were encountered in inserting, advancing, or withdrawing the device.The product was stored and handled according to the instructions for use (ifu), and no device damage was noticed prior to opening the package.There was no difficulty removing the device from sterile packaging, and it was prepped per the ifu without difficulty.No procedural cd was available.A non-sterile unit of product cath 4f inf 100 cm jr4 was received for analysis coiled inside a clear plastic bag.The device was unpacked to perform the product evaluation.The unit presented a separated condition located approximately 99 cm from the distal tip, with no other notable findings.Dimensional analysis was performed to verify the outer and inner diameters of the catheter near the damage, and the results were within specification.Visual inspection of the separated edges under magnification showed elongation and diameter reduction consistent with tensile and twist stress beyond the material yield strength.The separated luer hub section showed no damage to the strain relief, indicating the separation occurred within the body of the catheter.Overall, dimensional and visual evaluations were within specification, and the condition observed is consistent with material overload rather than a manufacturing or design-related deficiency.The reported malfunction ¿catheter (body/shaft) ¿ separated¿ was confirmed during the evaluation.The exact cause of the reported event cannot be found.We acknowledge the customer's report that the device was handled per the ifu.Information for safety is provided in the product¿s labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿to prevent damage to the catheter tip during removal or manipulation, avoid excessive force.¿ and ¿treat all 4f (1.35 mm) catheters and smaller french sizes with extra care to prevent kinking or separation.¿ based on the available information and product analysis, there is no evidence to suggest 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
The device was returned for evaluation.
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 22852067
• Report Number: 9616099-2025-01346
• Device Sequence Number: 14557652
• Product Code: DQO
• UDI-Device Identifier: 10705032014618
• UDI-Public: (01)10705032014618(17)280229(10)18432544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 538421
• Device Lot Number: 18432544
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 10/07/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 08/28/2025; 10/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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 ACIST INJECTOR
• Patient Sex: Unknown