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	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.E1: phone # (b)(6).
Event or Problem Description
As reported, while using the 5fr 110cm super torque marking pig catheter, two of the sizing rings on the catheters moved.One of which stayed on the catheter the other could not be located after the procedure.The catheter separated and broke off with part remaining in vessel.The piece was removed using a snare.The sizing ring moved prior to the measurement.This occurred during a leg procedure.There was no damage noted to the packaging of the device.No anomalies were observed when the device was taken out of the package, and no difficulties were experienced during preparation.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, while using the 5fr 110cm super torque marking pig catheter, two of the sizing rings on the catheters moved.One of which stayed on the catheter the other could not be located after the procedure.The catheter separated and broke off with part remaining in vessel.The piece was removed using a snare; however, the ring was not removed from the patient.The procedure was completed using the same catheter.The patient was reported to be ambulatory the following day.The sizing ring moved prior to the measurement.The procedure performed was a vascular intervention involving the legs.There was no damage noted to the packaging of the device.No anomalies were observed when the device was taken out of the package, and no difficulties were experienced during preparation.There was no damage to the packaging, and the product was stored in a cabinet.No anomalies were noted upon removal from the package.The device was prepped per the instructions for use (ifu) without difficulty.No resistance or friction was encountered while advancing the catheter through the sheath, no excess force was used, and there was no difficulty tracking through the vasculature.The device was not returned for analysis.A product history record (phr) review of lot 18293553 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band (supertorque mb) ¿ dislodged and catheter (body/shaft) ¿ separated¿ could not be substantiated because the device was not returned and images were not provided.Therefore, the exact cause of the event cannot be determined and use related factors 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), ¿manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm super torque® mb angiographic catheter positioning under high quality fluoroscopic observation.¿ based on the available information, there is no evidence to suggest the reported event is related to manufacturing or design issues.Therefore, no additional actions will be taken.
Event or Problem Description
As reported, while using the 5fr 110cm super torque marking pig catheter, two of the sizing rings on the catheters moved.One of which stayed on the catheter the other could not be located after the procedure.The catheter separated and broke off with part remaining in vessel.The piece was removed using a snare; however, the ring was not removed from the patient.The procedure was completed using the same catheter.The patient was reported to be ambulatory the following day.The sizing ring moved prior to the measurement.The procedure performed was a vascular intervention involving the legs.There was no damage noted to the packaging of the device.No anomalies were observed when the device was taken out of the package, and no difficulties were experienced during preparation.There was no damage to the packaging, and the product was stored in a cabinet.No anomalies were noted upon removal from the package.The device was prepped per the instructions for use (ifu) without difficulty.No resistance or friction was encountered while advancing the catheter through the sheath, no excess force was used, and there was no difficulty tracking through the vasculature.The device is not being returned for analysis.

• Brand Name: SUPER TORQUE MB
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60 avenue; miami lakes FL 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: 24344070
• Report Number: 9616099-2026-00272
• Device Sequence Number: 13220565
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)270228(10)18293553
• 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): 03/23/2026

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
• Device Catalogue Number: 532598B
• Device Lot Number: 18293553
• Was Device Available for Evaluation?: No
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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: UNKNOWN.
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Sex: Unknown