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

Catalog Number	533532
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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, two 5fr mp a2 supertorque plus catheters cracked at the hub when a syringe was attached.The devices were not used in the patient as the crack was noticed when the syringe was attached for flushing.The procedure was completed by opening and using a new mpa2 catheter.There was no reported injury to the patient.The products were stored properly according to the instructions for use (ifu), and there was no difficulty removing them from the packaging.No other damages were noted prior to inserting the products into the patient.The devices prepped normally, with a syringe attached to the catheters (x2) for flushing.The intended procedure was a right heart catheterization for blood sampling, targeting normal pa¿s, with no calcification in a pediatric patient.The vessel had no tortuosity.The syringe was not torqued against resistance when attaching to the catheter.And the second device will not be returned for evaluation.The first device will be returned for evaluation.
Event or Problem Description
As reported, two 5fr mp a2 supertorque plus catheters cracked at the hub when a syringe was attached.The devices were not used in the patient as the crack was noticed when the syringe was attached for flushing.The procedure was completed by opening and using a new mpa2 catheter.There was no reported injury to the patient.The products were stored properly according to the instructions for use (ifu), and there was no difficulty removing them from the packaging.No other damages were noted prior to inserting the products into the patient.The devices prepped normally, with a syringe attached to the catheters (x2) for flushing.The intended procedure was a right heart catheterization for blood sampling, targeting normal pa¿s, with no calcification in a pediatric patient.The vessel had no tortuosity.The syringe was not torqued against resistance when attaching to the catheter.And the second device will not be returned for evaluation.The first device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, two 5fr mp a2 supertorque plus catheters cracked at the hub when a syringe was attached.The devices were not used in the patient as the crack was noticed when the syringe was attached for flushing.The procedure was completed by opening and using a new mpa2 catheter.There was no reported injury to the.The products were stored properly according to the instructions for use (ifu), and there was no difficulty removing them from the packaging.No other damages were noted prior to inserting the products into the patient.The devices prepped normally, with a syringe attached to the catheters (x2) for flushing.The intended procedure was a right heart catheterization for blood sampling, targeting normal pa¿s, with no calcification in a pediatric patient.The vessel had no tortuosity.The syringe was not torqued against resistance when attaching to the catheter.And the second device will not be returned for evaluation.The first device will be returned for evaluation.One device was returned for evaluation and was evaluated under (b)(4) images of the second device were provided for review and analyzed under (b)(4).Four photos were sent for analysis.In the photos, a super torque unit from lot: 18363499 was seen.A splintered hub is noted from the luer hub and a fragment of the hub was left on a cover sheet.A product history record (phr) review of lot: 18363499 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The customer¿s complaint reported as ¿luer hub-splintered-fragments can be injected¿ was confirmed by product analysis for the device that returned (b)(4) and confirmed by photo analysis for the second device (b)(4).The fatigue striations found on the returned device suggest the material was subjected to tensile forces that exceeded the yield strength prior to splintering.The exact source of the tensile force cannot be found.Without returning the second device, the root cause cannot be determined either.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 to make 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 the 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: CARDIO DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue 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: 21282405
• Report Number: 9616099-2025-00148
• Device Sequence Number: 7908914
• Product Code: DQO
• UDI-Device Identifier: 10705032012546
• UDI-Public: (01)10705032012546(17)270831(10)18363499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914007
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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
• Device Catalogue Number: 533532
• Device Lot Number: 18363499
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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 Age: 7 YR
• Patient Sex: Male