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

Catalog Number	534518T
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when introducing a 5f 100cm judkins left (jl) 3.5 infiniti diagnostic catheter inside of the patient via the right radial artery, the patient reported being in pain.A spasm occurred in the right radial artery while advancing the catheter and was treated with medication.The physician removed the catheter from the patient, and a puncture was observed on the distal curve of the device.One image was provided, and it shows a punctured condition to the distal portion of the device, and it is distal to a fusion line.One video was provided, and it shows saline flowing from the puncture.A new 5f 100cm judkins left (jl) 3.5 infiniti diagnostic catheter was used as a replacement.The device was stored and prepped per the instructions for use (ifu).There was no damage to the device packaging prior to use, and there was no difficulty in removing the device from its packaging.The device was successfully flushed during preparation, and it was reported that saline was observed coming from the puncture at the distal tip during preparation.Vessel characteristics at the access site were neither calcified nor tortuous.The device was inserted over a 0.035¿x150 non-cordis guidewire, which was inserted into the distal tip of the catheter without any resistance or friction.Saline/contrast was injected into the catheter while it was inside the patient, positioned at the aortic staff.The device will be returned for evaluation.
Event or Problem Description
As reported, when introducing a 5f 100 cm judkins left (jl) 3.5 infiniti diagnostic catheter inside of the patient via the right radial artery, the patient reported being in pain.A spasm occurred in the right radial artery while advancing the catheter and was treated with medication.The physician removed the catheter from the patient, and a puncture was observed on the distal curve of the device after it was used inside of the patient.One image was provided, and it shows a punctured condition to the distal portion of the device, and it is distal to a fusion line.One video was provided, and it shows saline flowing from the puncture.A new 5f 100 cm judkins left (jl) 3.5 infiniti diagnostic catheter was used as a replacement.The device was stored and prepped per the instructions for use (ifu).There was no damage to the device packaging prior to use, and there was no difficulty in removing the device from its packaging.The device was successfully flushed during preparation.Vessel characteristics at the access site were neither calcified nor tortuous.The device was inserted over a 0.035' x 150 non-cordis guidewire, which was inserted into the distal tip of the catheter without any resistance or friction.Saline/contrast was injected into the catheter while it was inside the patient, positioned at the aortic staff.The device was returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d9, e1, g3, g6, h1, h2, h3, h6, and h11.A review of the manufacturing documentation associated with lot 18285617 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.The provided images have been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, when introducing a 5f 100cm judkins left (jl) 3.5 infiniti diagnostic catheter inside of the patient via the right radial artery, the patient reported being in pain.A spasm occurred in the right radial artery while advancing the catheter and was treated with medication.The physician removed the catheter from the patient, and a puncture was seen on the distal curve of the device after it was used inside of the patient.One image was provided, and it shows a punctured condition to the distal part of the device, and it is distal to a fusion line.One video was provided, and it shows saline flowing from the puncture.A new 5f 100cm judkins left (jl) 3.5 infiniti diagnostic catheter was used as a replacement.The device was stored and prepped with the instructions for use (ifu).There was no damage to the device packaging prior to use, and there was no difficulty in removing the device from its packaging.The device was successfully flushed during preparation.Vessel characteristics at the access site were neither calcified nor tortuous.The device was inserted over a 0.035¿x150 non-cordis guidewire, which was inserted into the distal tip of the catheter without any resistance or friction.Saline/contrast was injected into the catheter while it was inside the patient, positioned at the aortic staff.One photo and a video were attached to event-(b)(4), showing a puncture or cut at the brite tip/distal tip where leakage was present.No added anomalies or notable details were observed.A non-sterile unit of cath f5 inf jl 3.5 100cm was received coiled inside an unclouded plastic bag.Upon unpacking, a thorough inspection focused on the distal tip revealed a puncture.The damaged area was examined using a vision system, which identified plastic deformation, fatigue lines, and elongations on the edge of the material, with the damage path extending from the inside toward the outside surface.This type of damage is commonly associated with interaction with a sharp object or mechanical impact.It is likely that the same factors responsible for the elongations, plastic deformation, and fatigue lines also caused the puncture.Further inspection suggested that the material near the puncture had been affected by a sharp object from outside the device.The product analysis found no evidence linking the observed condition to the manufacturing or design process; therefore, no preventive or corrective actions will be taken at this time.A product history record (phr) review of lot: 18285617 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿vasospasm¿ cannot be substantiated with the information available.However, the reported ¿brite tip/distal tip ¿ puncture/cut¿ was observed during the product evaluation.Evaluation results indicate the damage was caused by interaction with a sharp object or mechanical impact.These damages may be related to procedural or handling factors, and the vasospasm may have resulted from fluid escaping through the puncture hole, potentially stimulating the vessel wall.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 information available and the phr review, 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 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: 22078417
• Report Number: 9616099-2025-00863
• Device Sequence Number: 9547893
• Product Code: DQO
• UDI-Device Identifier: 10705032013666
• UDI-Public: (01)10705032013666(17)270131(10)18285617
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 534518T
• Device Lot Number: 18285617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 07/03/2025; 07/30/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/19/2025; 07/28/2025; 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: 0.035¿ X 150 TEFLON GUIDEWIRE.; 5F 100 CM JL 3.5 INFINITI DIAGNOSTIC CATHETER.; UNKNOWN 5F INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown