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

Catalog Number	532598B
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 5f pigtail (pig) 110cm super torque mb diagnostic catheter became stuck on the guidewire during an aortomonoiliac endograft procedure and during the attempt to remove the device, the catheter broke, leaving approximately one-third at the patient¿s access site.This required partial removal of the guidewire and catheter through the introducer, followed by complete removal of the catheter, which was described as extremely difficult due to tight adhesion to the guidewire.There was a reported patient injury.The device was used for angiography and subsequent measurement of the endograft length required to complete the procedure.The procedure was performed as part of an endovascular aneurysm repair (evar) completion in a patient with an abdominal aortic aneurysm with a right type ib endoleak and a left type iii endoleak, with a rapidly enlarging aneurysm reaching 10 cm in diameter.The device will not 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 5f pigtail (pig) 110cm super torque mb diagnostic catheter became stuck on the guidewire during an aortomonoiliac endograft procedure and during the attempt to remove the device, the catheter broke, leaving approximately one-third at the patient¿s access site.This required partial removal of the guidewire and catheter through the introducer, followed by complete removal of the catheter, which was described as extremely difficult due to tight adhesion to the guidewire.There was a reported patient injury.The device was used for angiography and subsequent measurement of the endograft length required to complete the procedure.The procedure was performed as part of an endovascular aneurysm repair (evar) completion in a patient with an abdominal aortic aneurysm with a right type ib endoleak and a left type iii endoleak, with a rapidly enlarging aneurysm reaching 10 cm in diameter.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device will not be returned for evaluation.The product was not returned for analysis.A product history record (phr) review of lot 18440172 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter body/shaft ¿ resistance/friction ¿ inner lumen, catheter body/shaft ¿ separated and catheter body/shaft ¿ withdrawal difficulty ¿ through sheath¿ could not be substantiated because the device was not returned and no images or procedural films were provided.This device is contraindicated for evar procedures due to the potential for entrapment of the catheter between endovascular devices and the vessel wall.Therefore, entrapment cannot be ruled out as a potential root 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, ¿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, there is no indication that the event is related to the design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, a 5f pigtail (pig) 110cm super torque mb diagnostic catheter became stuck on the guidewire during an aortomonoiliac endograft procedure and during the attempt to remove the device, the catheter broke, leaving approximately one-third at the patient¿s access site.This required partial removal of the guidewire and catheter through the introducer, followed by complete removal of the catheter, which was described as extremely difficult due to tight adhesion to the guidewire.There was a reported patient injury.The device was used for angiography and subsequent measurement of the endograft length required to complete the procedure.The procedure was performed as part of an endovascular aneurysm repair (evar) completion in a patient with an abdominal aortic aneurysm with a right type ib endoleak and a left type iii endoleak, with a rapidly enlarging aneurysm reaching 10 cm in diameter.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device will not be returned for evaluation.

• 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: 23080555
• Report Number: 9616099-2025-01500
• Device Sequence Number: 20030059
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)280331(10)18440172
• 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): 10/24/2025

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: 18440172
• 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: 08/23/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• 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: NO FURTHER DETAILS AT THIS TIME
• Patient Sex: Unknown