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	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 5f 110cm super torque marker band pigtail diagnostic catheter ruptured in the patient¿s iliac artery during use.The fragment was recovered during surgery.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu), there was no damage to the device prior to use, and there was no difficulty advancing the device within the patient prior to the rupture.Additional details were requested but were unknown.The device will be returned for evaluation.
Additional Manufacturer Narrative
Please note that a phone number for the initial reporter was not provided.Therefore, "+000(000)0000000" was entered due to system requirements.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, d9, g3, g6, h1, h2, h3, and h11.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
Complaint conclusion: as reported, a 5f 110cm super torque marker band pigtail diagnostic catheter ruptured in the patient¿s iliac artery during use.The fragment was recovered during surgery.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu), there was no damage to the device prior to use, and there was no difficulty advancing the device within the patient prior to the rupture.Additional details were requested but were unknown.One cath mb 5f pig 110cm 6sh, catalog number 532598b, was received for evaluation.Visual inspection under unaided conditions identified a complete separation of the catheter body located approximately 85.5 cm from the distal tip.The marker band was also observed to be offset and out of position from its expected location along the distal region of the catheter shaft.No additional components were received with the unit, and aside from the reported separation and marker band displacement, no other visible abnormalities were identified during the visual examination.Dimensional evaluation was performed in the region corresponding to the separation site, approximately 85.5 cm from the distal tip, to verify the outer diameter and inner diameter.The measured outer diameter at the affected location was 0.0685 in and was within specification.The inner diameter was also verified and found to be within specification.Additional dimensional measurements were obtained at the distal section of the catheter near the area where the marker band was observed to be out of position, and both the outer diameter measurement of 0.0685 in and the inner diameter verification were within specification, indicating no dimensional abnormalities in the distal shaft region associated with the marker band displacement.A guidewire insertion evaluation, consisting of inserting a guidewire through the catheter, could not be performed because the separation condition of the received unit prevented insertion through the catheter lumen as required for the procedure.High-magnification evaluation of the separated interface identified morphological characteristics indicative of plastic deformation, consistent with material response to mechanical overstress.Microscopic inspection of the marker band region also confirmed that the marker band was displaced from its intended position.Overall, the returned unit exhibited a catheter body separation located approximately 85.5 cm from the distal tip and a marker band offset and out-of-position condition along the distal section of the catheter shaft.Dimensional analysis at the separation location and at the distal section near the displaced marker band confirmed that the outer diameter and inner diameter measurements were within the applicable specification.Functional evaluation could not be completed because the separation condition prevented guidewire insertion through the catheter lumen.Microscopic evaluation of the separated interface revealed evidence of plastic deformation associated with the separation condition.The observed plastic deformation is consistent with mechanical overstress and does not present characteristics indicative of manufacturing-related anomalies.These features indicate that mechanical damage combined with progressive material fatigue contributed to the failure.In addition, microscopic inspection confirmed that the marker band was displaced from its intended position.Based on the visual, dimensional, and microscopic findings, there is no evidence to associate the observed condition with the manufacturing or design process.The reported ¿catheter (body/shaft) ¿ separated¿ was observed and the exact cause of the event cannot be determined.Evaluation results found mechanical stress contributed to the failure.Therefore, use related factors cannot be excluded.The same mechanical stress may have contributed to the displacement of the marker bands.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.

• 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: 24222883
• Report Number: 9616099-2026-00166
• Device Sequence Number: 8579398
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)280531(10)18468426
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: 18468426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 01/22/2026; 03/11/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/17/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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
• Patient Sex: Unknown