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

Catalog Number	534619T
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	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 6f 100 cm judkins right (jr) infiniti diagnostic catheter was found cut when the nurse tried to remove it from its packaging.Once prepared and in the cardiologist's hands, while preparing to pass it through the guidewire, the catheter was stretched and approximately 6 cm was cut from the tip.There was no reported patient injury.The planned procedure was cardiac resynchronization device implantation.The product was stored and handled according to the instructions for use (ifu).There was no difficulty removing the device from the sterile packaging, and the device was prepared according to the ifu.The sterile bag was not received open or damaged.It is not possible that the product was intentionally opened before use and, due to unuse, was put back in storage.The condition was checked before use, upon receipt of the product, and after receipt and storage in the laboratory before use.The device was stored in its original packaging.Another infiniti was used to complete the procedure.There was no reported patient injury.An image of the catheter was provided, showing a separation near the distal end of the device.The catheter is secured to a mounting card using retention tabs.Additionally, a small dark spot, appearing to be a non-movable particle, is visible on the surface of the mounting card.The device is expected to be returned for evaluation.
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
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.
Event or Problem Description
The device was returned for evaluation.
Additional Manufacturer Narrative
As reported, a 6f 100 cm judkins right (jr) infiniti diagnostic catheter was found cut when the nurse tried to remove it from its packaging.Once prepared and in the cardiologist's hands, while preparing to pass it through the guidewire, the catheter was stretched and approximately 6 cm was cut from the tip.There was no reported patient injury.The planned procedure was cardiac resynchronization device implantation.The product was stored and handled according to the instructions for use (ifu).There was no difficulty removing the device from the sterile packaging, and the device was prepared according to the ifu.The sterile bag was not received open or damaged.It is not possible that the product was intentionally opened before use and, due to unuse, was put back in storage.The condition was checked before use, upon receipt of the product, and after receipt and storage in the laboratory before use.The device was stored in its original packaging.Another infiniti was used to complete the procedure.There was no reported patient injury.An image of the catheter was provided, showing a separation near the distal end of the device.The catheter is secured to a mounting card using retention tabs.Additionally, a small dark spot, appearing to be a non-movable particle, is visible on the surface of the mounting card.The device is expected to be returned for evaluation.A non-sterile unit of catheter cath f6inf tl jr 3.5 100cm was received coiled inside a transparent plastic bag.Upon unpacking for evaluation, visual inspection revealed the device was separated 9 cm from the distal tip, with no other visible anomalies.Amplified imaging showed elongation on both internal and external catheter surfaces, showing localized plastic deformation typically caused by mechanical stress.Transferred material was seen at the separation site, suggesting frictional interaction or displacement during the failure event.These findings strongly support that the separation was the result of external mechanical handling or applied tensile forces and not related to a manufacturing deficiency.No microstructural anomalies were noted to show intrinsic material flaws.Additionally, a blackish inclusion was embedded in the catheter body; dimensional analysis confirmed it met the required specifications, classifying it as an acceptable manufacturing artifact.Inner and outer diameter measurements near the damaged area were also within specification.Although the inclusion is manufacturing-related, it is compliant with quality control requirements, and the separation itself is attributed to post-manufacture mechanical stress.No corrective or preventive actions will be taken.T the reported issues, ¿brite tip/distal tip ¿ separated¿ and ¿catheter (body/shaft) ¿ foreign material,¿ were confirmed during the product evaluation.The separated sections of the device showed evidence of mechanical stress, although the source of the stress could not be found.The inclusion seen on the catheter body was identified as a manufacturing artifact and found to be within specification.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ 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.

• 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: 22044300
• Report Number: 9616099-2025-00851
• Device Sequence Number: 15707779
• Product Code: DQO
• UDI-Device Identifier: 10705032014175
• UDI-Public: (01)10705032014175(17)270331(10)18306029
• 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,Followup
• Report Date (Section B): 07/22/2025

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: 18306029
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 07/15/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 85 KG