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

Catalog Number	533552
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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, the hub of a 5.2f judkin's right (jr) 4 100cm super torque plus diagnostic catheter was cracked, making it impossible to attach a syringe.The procedure was completed using a different unit.There was no reported patient injury.The device hub was found cracked after opening the device.There was no reported damage to the packaging prior to opening, and the device was stored and prepared per the instructions for use.The device was pulled from the packaging by the hub and was not torqued or steered by it.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the hub of a 5.2f judkin's right (jr) 4 100cm super torque plus diagnostic catheter was cracked, making it impossible to attach a syringe.The procedure was completed using a different unit.There was no reported patient injury.The device hub was found cracked after opening the device.There was no reported damage to the packaging prior to opening, and the device was stored and prepared per the instructions for use.The device was pulled from the packaging by the hub and was not torqued or steered by it.The device was not returned for evaluation.The non-sterile catheter cath f5.2+ jr4 100cm was received coiled inside a clear plastic bag and presented no visible damage upon initial inspection, with no additional notable observations.Torque stress was applied to the luer hub using a syringe, which revealed a cracked condition.Vision-system inspection of the cracked region showed fatigue striations on the luer hub surface, which are commonly associated with separations resulting from material tensile overload, indicating that the hub material was likely subjected to a tensile force exceeding its yield strength prior to cracking.A secondary inspection again confirmed no visible damage to the luer hub before torque was applied, and the same cracked condition and fatigue striations were observed.Although fatigue features were present, the exact cause of the condition could not be conclusively determined based on the available evidence.The reported ¿luer hub ¿ cracked¿ was seen during the product evaluation.The exact cause of the event cannot be found; however, the signs of mechanical interaction or stress noted during the product evaluation indicate handling factors may be a contributing factor.Information for safety is provided in the product¿s labeling with the intent of making the user aware of the risks.The current device labeling does not include specific warnings about the user¿s experience.The event is consistent with localized mechanical stress, potentially related to handling factors such as over-tightening or external compression.Prevention of such occurrences is addressed through operator training and adherence to standard interventional practice.The labeling includes a precaution stating that the device is intended for use only by physicians trained and experienced in diagnostic and interventional catheterization techniques.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: SUPER TORQUE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 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: 23352457
• Report Number: 9616099-2025-01701
• Device Sequence Number: 15683144
• Product Code: DQO
• UDI-Device Identifier: 10705032012676
• UDI-Public: (01)10705032012676(17)280531(10)18470718
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862244
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 533552
• Device Lot Number: 18470718
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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