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

Catalog Number	532598B
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
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 marker band of a 5f pig 110cm super torque marker band (mb) diagnostic catheter was insufficiently bonded to the catheter shaft and showed movement.The device was not used for the procedure.There was no reported patient injury.The physician attempted to use the catheter during a percutaneous coronary intervention (pci) procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the physician attempted to use a 5f pig 110cm super torque marker band (mb) diagnostic catheter however, the marker band was insufficiently bonded to the catheter shaft and showed movement.Therefore, the device was not used for the procedure.There was no reported patient injury.The physician attempted to use the catheter during a percutaneous coronary intervention (pci) procedure.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The non-sterile cath mb 5f pig 110cm 65h unit was received coiled inside a clear plastic bag and unpacked for evaluation.Inspection confirmed that the 10 marker bands were out of position and that the marker bands from numbers 11 to 20 had shifted from their manufacturing locations, with all 20 bands present and none missing as verified from distal end to hub.Dimensional checks of id and od on the body shaft showed measurements out of specification in the region between the assigned marker band locations, attributed to band displacement and resulting deformation of the catheter body affecting both internal and external diameter.A 0.038" guidewire was inserted through the distal tip but could not traverse the entire length of the catheter, stopping near the first misaligned band due to deformation; insertion and withdrawal also failed.Vision system inspection confirmed that the marker band surfaces did not show scratches, peelings, or abrasions.Overall inspection confirmed 10 marker bands displaced and corresponding dimensional deviations due to deformation of the catheter body; however, the exact cause of the condition could not be conclusively determined, and no evidence suggested the event was related to manufacturing or design.The observed ¿marker band ¿ offset/out of position ¿ prior to/during measurement¿ was seen during the product evaluation.Stretching of the catheter could result in marker bands moving along the catheter.The information provided did not confirm user compliance with the device labeling therefore handling factors that resulted in catheter stretching cannot be excluded.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, ¿stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.¿ 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 MB
• 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: 23463328
• Report Number: 9616099-2025-01730
• Device Sequence Number: 16019635
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)280229(10)18431922
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 12/10/2025

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: 532598B
• Device Lot Number: 18431922
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown