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

Catalog Number	534642T
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	11/19/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported, a 6f.070-inch multipurpose (mp) a2 100cm infiniti diagnostic catheter was found to be separated upon opening, when the operator was preparing to start the procedure.Upon opening the inner package, the separation of the tube body was observed.The reported issue described as ¿broken¿ referred to the catheter head end being separated from the tube body when the package was opened.Another infiniti catheter was used to complete the procedure.There was no reported patient injury.The intended procedure was transcatheter aortic valve implantation (tavi).The product was stored and handled according to the instructions for use (ifu).Upon opening the inner package, the separation of the tube body was observed.The inner package was torn open, and the cardboard was attached together with the catheter.No other damage was noted.There was no difficulty removing the device from the sterile packaging.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 6f.070-inch multipurpose (mp) a2 100cm infiniti diagnostic catheter was found to be separated upon opening, when the operator was preparing to start the procedure.Upon opening the inner package, the separation of the tube body was observed.The reported issue described as ¿broken¿ referred to the catheter head end being separated from the tube body when the package was opened.Another infiniti catheter was used to complete the procedure.There was no reported patient injury.The intended procedure was transcatheter aortic valve implantation (tavi).The product was stored and handled according to the instructions for use (ifu).Upon opening the inner package, the separation of the tube body was observed.The inner package was torn open, and the cardboard was attached together with the catheter.No other damage was noted.There was no difficulty removing the device from the sterile packaging.The product was not returned for analysis.No lot number was provided; therefore, a product history record (phr) review could not be generated.The reported "brite tip/distal tip separated¿ could not be verified as the device was not returned for analysis.The exact cause cannot be determined.Without the return of the device for analysis and with the limited additional information provided, it is difficult to ascertain the root cause between the device and the event reported.According to the instructions for use, which are not intended to mitigate risk, ¿precautions: store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54oc (130of) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters, and specifically the 4f (1.35 mm) infiniti® pigtail catheters: 1.Straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.2.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ without a lot number to conduct a phr review and without the return of the device for analysis, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• 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: 24071542
• Report Number: 9616099-2026-00098
• Device Sequence Number: 15735841
• Product Code: DQO
• UDI-Device Identifier: 10705032014304
• UDI-Public: (01)10705032014304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• 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): 02/19/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 534642T
• 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: 12/21/2025
• Supplement Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Sex: Unknown