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

Catalog Number	534619T
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
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, there was a foreign body protruding from the head end of the 6f 100cm judkin's right (jr) 3.5 infiniti diagnostic catheter when the package was opened and the product was checked.The procedure was completed by changing to a new catheter.There were no reports of patient injury.This delayed the patient's diagnosis and treatment and did not cause any other damage to the patient.No damages were found on the device or device packaging prior to opening.The patient was admitted to the catheterization laboratory for coronary angiogram (cag) examination and was prepared to apply the contrast catheter to view the coronary arteries.After discovering the issue, the catheter was immediately replaced with a new one and applied after checking that there was no problem.The device was stored and prepped in accordance with the instructions for use (ifu).A contralateral approach was not used.The surgeon did not provide the vessel characteristics at the target site or the access site.The device was not pulled from the packaging by the hub, nor was it torqued or "steered" by the hub.No difficulties were encountered while attempting to insert, advance, or withdraw the device.The user was trained in the use of the device.The hospital reported this case as a serious injury adverse event to china nmpa directly.The device was not returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, there was a foreign body protruding from the head end of the 6f 100cm judkin's right (jr) 3.5 infiniti diagnostic catheter when the package was opened and the product was checked.The procedure was completed by changing to a new catheter.There were no reports of patient injury.This delayed the patient's diagnosis and treatment and did not cause any other damage to the patient.No damages were found on the device or device packaging prior to opening.The patient was admitted to the catheterization laboratory for coronary angiogram (cag) examination and was prepared to apply the contrast catheter to view the coronary arteries.After discovering the issue, the catheter was immediately replaced with a new one and applied after checking that there was no problem.The device was stored and prepped in accordance with the instructions for use (ifu).A contralateral approach was not used.The surgeon did not provide the vessel characteristics at the target site or the access site.The device was not pulled from the packaging by the hub, nor was it torqued or "steered" by the hub.No difficulties were encountered while attempting to insert, advance, or withdraw the device.The user was trained in the use of the device.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18291193 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint ¿catheter (body/shaft) foreign material" could not be evaluated.The cause of the reported issue could not be determined.Unspecified handling and/or storage issues may have contributed to the reported issue.Users should inspect for any signs of damage prior to and during use.Any product with damage should not be used.Based on the information available for 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: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 avenue; miami lakes, florida 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: 22067357
• Report Number: 9616099-2025-00862
• Device Sequence Number: 8703162
• Product Code: DQO
• UDI-Device Identifier: 10705032014175
• UDI-Public: (01)10705032014175(17)270131(10)18291193
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 534619T
• Device Lot Number: 18291193
• 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: 04/26/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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 Age: 89 YR
• Patient Sex: Female