MAUDE Adverse Event Report: CORDIS CORPORATION SUPER TORQUE PLUS; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	533693
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the doctor noticed that the short portion just below the hub on the 6fr mpac super torque catheter had crumbled into small pieces.The team pulled another 6fr mpac super torque, and upon inspection, saw that it had a defect in the same place as the crumbled catheter.There was no reported injury to the patient.This occurred during a routine heart catheterization.The device was stored and prepped in accordance with the instructions for use (ifu).The devices are stored on a hanger behind a glass door.The device receives fluorescent light exposure when stored.The devices are not stored in the white outer box until they are used.They are stored in cabinets with transparent doors (glass).The shipment of devices is not stored in an environment that is not climate controlled at any point before being stored in the lab.The device is not reprocessed or re-sterilized.The device is not exposed to uv lighting or any form of sterilization process at any point.The lab does not use any sort of uv or sterilization process in general.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the doctor noticed that the short portion just below the hub on the 6fr mpac super torque catheter had crumbled into small pieces.The team pulled another 6fr mpac super torque, and upon inspection, saw that it had a defect in the same place as the crumbled catheter.There was no reported injury to the patient.This occurred during a routine heart catheterization.The device was stored and prepped in accordance with the instructions for use (ifu).The devices are stored on a hanger behind a glass door.The device receives fluorescent light exposure when stored.The devices are not stored in the white outer box until they are used.They are stored in cabinets with transparent doors (glass).The shipment of devices is not stored in an environment that is not climate controlled at any point before being stored in the lab.The device is not reprocessed or re-sterilized.The device is not exposed to uv lighting or any form of sterilization process at any point.The lab does not use any sort of uv or sterilization process in general.The device will be returned for evaluation.Two images were provided.The first image shows the proximal portion of a catheter, with all but a small piece of the strain relief missing.The remaining portion has a jagged edge.The hub appears to have a yellowish discoloration.The second image shows the body/shaft of the catheter that should be under the strain relief and a longitudinal scratch that does not appear to be full thickness is noted.
Event or Problem Description
As reported, the doctor noticed that the short portion just below the hub on the 6fr mpac super torque catheter had crumbled into small pieces.The team pulled another 6fr mpac super torque, and upon inspection, saw that it had a defect in the same place as the crumbled catheter.There was no reported injury to the patient.This occurred during a routine heart catheterization.The device was stored and prepped in accordance with the instructions for use (ifu).The devices are stored on a hanger behind a glass door.The device receives fluorescent light exposure when stored.The devices are not stored in the white outer box until they are used.They are stored in cabinets with transparent doors (glass).The shipment of devices is not stored in an environment that is not climate controlled at any point before being stored in the lab.The device is not reprocessed or re-sterilized.The device is not exposed to uv lighting or any form of sterilization process at any point.The lab does not use any sort of uv or sterilization process in general.The device will be returned for evaluation.Two images were provided.The first image shows the proximal portion of a catheter, with all but a small piece of the strain relief missing.The remaining portion has a jagged edge.The hub appears to have a yellowish discoloration.The second image shows the body/shaft of the catheter that should be under the strain relief and a longitudinal scratch that does not appear to be full thickness is noted.
Additional Manufacturer Narrative
As reported, the doctor noticed that the short portion just below the hub on the 6fr mpac super torque catheter had crumbled into small pieces.The team pulled another 6fr mpac super torque, and upon inspection, saw that it had a defect in the same place as the crumbled catheter.There was no reported injury to the patient.This occurred during a routine heart catheterization.The device was stored and prepped following the instructions for use (ifu).The devices are stored on a hanger behind a glass door.The device receives fluorescent light exposure when stored.The devices are not stored in the white outer box until they are used.They are stored in cabinets with transparent doors (glass).The shipment of devices is not stored in an environment that is not climate controlled at any point before being stored in the lab.The device is not reprocessed or re-sterilized.The device is not exposed to uv lighting or any form of sterilization process at any point.The lab does not use any sort of uv or sterilization process in general.The device will be returned for evaluation.Two images were provided.The first image shows the proximal part of a catheter, with all but a small piece of strain relief missing.The remaining part has a jagged edge.The hub appears to have yellowish discoloration.The second image shows the body/shaft of the catheter that should be under strain relief and a longitudinal scratch that does not appear to be full thickness is noted.A non-sterile catheter ¿cath mpac stp 6f¿ was received coiled inside a clear plastic bag and unpacked for product evaluation.Inspection of the unit focused on the strain relief, which was found to be degraded, with material missing.The luer hub also presented a yellowish discoloration.No other abnormalities were noted.Visual inspection of the strain relief area using a vision system confirmed the degraded condition.The damage is consistent with environmental degradation, likely resulting from exposure to ultraviolet light, thermal stress, or chemical agents, rather than mechanical stress.The reported ¿strain relief-degradation¿ and ¿catheter (body/shaft)-damaged¿ were not seen during the analysis of complaint 2025-14751-1.However, a molding mark determined to be part of the manufacturing process was found on the strain relief.The findings were found to be within specifications; therefore, no actions will be taken.The reported ¿strain relief-degradation¿ was seen while analyzing the device associated with 2025-14751-2.However, no other damages were found on the body of the device.The exact cause of the degradation is unknown.Users are trained to inspect devices for signs of damage prior to and during use, and any product found to be damaged should not be used.Information for safety is provided in the product labeling to ensure users are aware of associated risks.According to the instructions for use (ifu)¿though not intended as a mitigation of risk¿it is noted: ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54ºc (130ºf) may damage the catheter.¿ based on the available information and findings from product analysis, the exact cause of the strain relief degradation cannot be determined at this time.As a result, an investigation has been initiated to further assess potential contributing factors.No further action will be taken at this time.

• Brand Name: SUPER TORQUE PLUS
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 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: 21955953
• Report Number: 9616099-2025-00757
• Device Sequence Number: 7227078
• Product Code: DQO
• UDI-Device Identifier: 10705032013574
• UDI-Public: (01)10705032013574(17)290131(10)18414273
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2025

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
• Device Catalogue Number: 533693
• Device Lot Number: 18414273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 06/24/2025
• Initial Report FDA Received Date: 05/04/2025
• Supplement Report FDA Received Date: 05/30/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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