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

Catalog Number	533580
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
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 im 100cm super torque plus diagnostic catheter was noted to be cracked during preparation after the sterile package had been opened.The procedure was completed successfully using a different unit.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use, and the user was trained in its operation.No damages were observed on the device or packaging prior to opening.The device will be returned for evaluation.
Additional Manufacturer Narrative
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
As reported, the hub of a 5.2f im 100cm super torque plus diagnostic catheter was noted to be cracked during preparation after the sterile package had been opened.The procedure was completed successfully using a different unit.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use, and the user was trained in its operation.No damages were observed on the device or packaging prior to opening.A non-sterile catheter cath f5.25t+ i m 100cm was received coiled inside a clear plastic bag and unpacked for evaluation.Visual inspection focused on the luer hub, which showed no visible damage or other notable findings.When torque was applied using a syringe attached to the luer hub, a cracked condition was revealed.Inspection of the cracked area using a vision system showed fatigue striations on the luer hub material, which are commonly associated with separations caused by tensile overload.This suggests the hub material experienced a tensile force that exceeded its yield strength prior to cracking; however, the exact cause of the condition could not be conclusively determined.A product history record (phr) review of lot 18432925 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.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 regarding 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 PLUS
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14021 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: 23352203
• Report Number: 9616099-2025-01699
• Device Sequence Number: 21101368
• Product Code: DQO
• UDI-Device Identifier: 10705032012843
• UDI-Public: (01)10705032012843(17)280229(10)18432925
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 533580
• Device Lot Number: 18432925
• 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: 10/28/2025; 12/04/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/22/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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 Sex: Unknown