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

Model Number	N/A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was cracking of the casing near the hub of two 6f infiniti pigtail 110cm 6sh diagnostic catheters.There was no reported patient injury.The device was never used.The cracking was noticed by scrub tech after opening package.Three images were provided for review.One of them shows a catheter with a strain relief that shows signs of degradation.The device was not returned as expected.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.Additional information is pending and will be submitted within 30 days upon receipt.A review of the manufacturing documentation associated with lot 18321845 presented no issues during the manufacturing process that can be related to the reported event.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, there was cracking of the casing near the hub of a 6f infiniti pigtail 110cm 6sh diagnostic catheter.There was no reported patient injury.The device was never used.The cracking was noticed by scrub tech after opening package.An image was provided for review.The picture shows a catheter with a strain relief that shows signs of degradation.Per the account, there may have been a second pigtail with the same issue.No additional information related to this device was provided.The devices associated were not returned as expected.One photograph was attached to event-2025-17064.The image shows what appears to be a dx catheter with degraded strain relief.No other anomalies or notable details were observed.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.¿ while this guidance mitigates risks associated with storage and handling, 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; 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: 22822500
• Report Number: 9616099-2025-01335
• Device Sequence Number: 8832248
• Product Code: DQO
• UDI-Device Identifier: 10705032014397
• UDI-Public: (01)10705032014397(17)270430(10)18321845
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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 Model Number: N/A
• Device Catalogue Number: 534650S
• Device Lot Number: 18321845
• Was Device Available for Evaluation?: Yes
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 10/24/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/01/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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 Sex: Unknown