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

Catalog Number	532501
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	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 5f 100cm super torque sidewinder simmons technique i (sim1), polyurethane diagnostic catheter has torn off.There were no reports of patient injury.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
Account/initial reporter information was updated.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 5f 100cm super torque sidewinder simmons technique i (sim1), polyurethane diagnostic catheter has torn off.There were no reports of patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.A non-sterile cath st 5f sim 1 100cm catheter was received coiled inside a clear plastic bag and unpacked for evaluation.Visual inspection revealed a separation on the catheter body approximately 2.7 cm from the hub, with no other visible damage or anomalies noted.Dimensional analysis of the outer and inner diameters of the catheter body confirmed that measurements were within specification.Due to the observed separation, magnified images were taken of the affected area.Elongation and stretching of the plastic material were observed at the separation site, characteristics commonly associated with tensile overload.These findings suggest the separation was likely caused by excessive tensile stress applied to the catheter body during handling or use.The reported "catheter (body/shaft) ¿ separated" was confirmed during product evaluation and was caused by excessive tensile forces that exceeded the material¿s yield strength.However, the source of the excessive force remains unknown.Torquing against resistance is a possible cause.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 results of 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: SUPER TORQUE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 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: 22129374
• Report Number: 9616099-2025-00917
• Device Sequence Number: 7343460
• Product Code: DQO
• UDI-Device Identifier: 10705032011648
• UDI-Public: (01)10705032011648(17)270930(10)18374535
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K915836
• 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): 08/13/2025

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: 532501
• Device Lot Number: 18374535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 08/13/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 08/05/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: NOT AVAILABLE
• Patient Sex: Unknown