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

Catalog Number	534660T
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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, a 6f tl im 100cm infiniti diagnostic catheter was found to have loose shards in an unopened package.There was no reported patient injury.Two images were provided for review.Blue polymer flakes can be seen within the packaging, and they appear to originate from the strain relief.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 6f tl im 100cm infiniti diagnostic catheter was found to have loose shards in an unopened package.There was no reported patient injury.The device was not opened or used on the patient.Two images were provided for review.Blue polymer flakes can be seen within the packaging, and they appear to originate from the strain relief.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was not returned for evaluation.Two photos were attached to event (b)(4) and to the picture analysis task and show an infiniti dx catheter from lot 18356356, ref (b)(4).Visual review of the images identified evidence of degradation at the strain relief, with blue flakes observed on the inside of the pouch.No other anomalies, damage, or notable findings were observed in the images, and no additional concerns were identified based on the available photographic evidence.A product history record (phr) review of lot 18356356 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿strain relief ¿ degradation¿ was seen during the photo analysis.Based on the available information, the specific cause of the degradation could not be determined.Potential contributing factors include storage or handling conditions within the reporting facility or factors associated with the manufacturing process of the unit.Users are trained to inspect products for signs of damage prior to and during use, and any product showing damage is not to be used.The product labeling includes information for safety intended to make users aware of such risks.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not expose to organic solvents.¿ while this guidance mitigates risks associated with storage, it does not eliminate the potential for degradation.Because a potential link to the manufacturing process could not be excluded, an investigation has been initiated to further evaluate potential contributing factors and implement further actions as appropriate.No additional actions will be taken at this time.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 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: 23507331
• Report Number: 9616099-2025-01796
• Device Sequence Number: 21081052
• Product Code: DQO
• UDI-Device Identifier: 10705032014441
• UDI-Public: (01)10705032014441(17)270731(10)18356356
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2025

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: 534660T
• Device Lot Number: 18356356
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/09/2025
• Supplement Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown