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

Catalog Number	532598B
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	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a gold marker on a 5f 110cm 6 side-hole (sh) super torque marker band (mb) diagnostic catheter has come off the catheter.There were no reports of patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a gold marker on a 5f 110cm 6 side-hole (sh) super torque marker band (mb) diagnostic catheter has come off the catheter.There were no reports of patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18438070 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint ¿marker band (supertorque mb) dislodged¿ could not be evaluated.With the limited information provided, without the return of the device, and with no procedural films, the cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy contributed to the reported event.According to the instruction for use (ifu), cordis angiographic catheters with marker bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.The instructions for use cautions users to inspect for any signs of damage prior to and during use.The ifu instructs any product with damage to not be used.Contraindications: do not use the super torque mb catheter in procedures where entrapment of the catheter between endovascular devices and the vessel wall may occur, for example endovascular aortic repair (evar) procedures.Based on the information available for review, there is no indication to suggest that the reported incident could be related to the design or manufacturing process of the units.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.; 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: 22516491
• Report Number: 9616099-2025-01123
• Device Sequence Number: 8011512
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)280331(10)18438070
• 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): 08/15/2025

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: 18438070
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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: UNKNOWN.
• Patient Sex: Unknown