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

Catalog Number	532598C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 5f 65cm 8 sidehole (sh) super torque marker band (mb) flush catheter was found to be disintegrating.Another catheter in the package showed visible damage at the hub.Two images were received for review: one showing the product labeling and the other showing the proximal portion of a catheter inside the packaging with the strain relief appearing cracked and portions of it missing.There were no reports of patient injury.In sum, 2 out of the 4 catheters being returned had the same issues.None of the catheters were used on the patient; one was opened, and disintegration was noticed before actual use.There were no damages found on the device or device packaging prior to opening.The device was stored and prepped in accordance with the instructions for use (ifu).There were no reports of patient injury.The procedure was completed using a new catheter.The user was trained in the use of the device.The user pulled all lot numbers from the shelf and is sending back a total of four catheters for evaluation.
Additional Manufacturer Narrative
This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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, the 5f 65cm 8 sidehole (sh) super torque marker band (mb) flush catheter was found to be disintegrating.Another catheter in the package showed visible damage at the hub.Two images were received for review: one showing the product labeling and the other showing the proximal portion of a catheter inside the packaging with the strain relief appearing cracked and portions of it missing.There were no reports of patient injuries.In sum, 2 out of the 4 catheters being returned had the same issues.None of the catheters were used on the patient; one was opened, and disintegration was noticed before actual use.No damages were observed on either the device or its packaging before opening.The device was stored and prepped in accordance with the instructions for use (ifu).There were no reports of patient injuries.The procedure was completed using a new catheter.The user was trained in the use of the device.All lot numbers were removed from the shelf, and a total of four catheters are being returned for evaluation.Two images related to the reported failure were provided by the customer for event 2025-16173.The first image displays the product labeling, while the second image shows the proximal portion of a catheter inside its packaging.In the second image, the strain relief appears cracked, with portions visibly missing.Four devices were subsequently received for analysis.Three exhibited signs of degradation, while one did not.The customer made allegations involving two of the devices, and an additional device also showed degradation.The fourth device showed no degradation; therefore, a complaint is not required, as no malfunction was alleged for it.The devices were evaluated under 2025-16173-1, 2025-16173-2, and 2025-16173-3.The review of the unaffected device is included in the product evaluation for 2025-16173-1.2025-16173-1 two units of the cath mb 5f pig 65cm 8sh were received for evaluation.One unit arrived non-sterile, coiled inside a plastic bag, and the other arrived sterile within a properly sealed manufacturing pouch.The non-sterile catheter was unpacked for visual inspection, which revealed discoloration with a yellowish hue on the hub and evidence of degradation at the strain relief.The sterile catheter was appropriately packaged, and its sterility was not compromised.Both units exhibited kinks consistent with folding to fit inside the plastic bag.A detailed visual inspection of the sterile catheter under proper lighting and magnification revealed no evidence of degradation or other anomalies.Degradation in the non-sterile unit is typically associated with environmental exposure such as uv light, elevated temperatures, or chemical contact.2025-16173-2 a sterile unit of the cath mb 5f pig 65cm 8sh was received packaged in a properly sealed manufacturing pouch, and the sterility was not compromised.The device was folded to fit inside a plastic bag and exhibited kinks corresponding to the folds formed during packaging.Visual inspection of the strain relief revealed a yellowish discoloration and evidence of material degradation on the hub.This failure mode has already been escalated under complaint -1, and the current complaint is part of the same event.The sterile catheter underwent a detailed visual inspection under appropriate lighting and magnification to assess for signs of degradation or anomalies.No additional indications of material degradation were observed beyond those initially identified.Degradation is generally associated with environmental exposure factors such as ultraviolet radiation, elevated temperatures, or chemical contact.The root cause of the observed degradation could not be determined during the product evaluation.2025-16173-3 a sterile unit of the cath mb 5f pig 65cm 8sh was received in a properly sealed manufacturing pouch with sterility uncompromised.The device arrived folded to fit inside a plastic bag and exhibited kinks corresponding to the folds created during packaging.Visual inspection of the strain relief revealed a cracked condition consistent with material degradation.This failure mode has already been escalated under complaint -1, and the current complaint is part of the same event.The observed degradation is typically associated with environmental exposure factors such as ultraviolet radiation, thermal stress, or chemical agents.The root cause of the degradation could not be determined during the product evaluation.The reported ¿strain relief degradation¿ was observed in three of the returned devices.One device showed no signs of degradation during evaluation, and no allegations of device malfunction were reported for it; therefore, a fourth complaint was not required.Degradation is generally associated with environmental exposure factors such as ultraviolet radiation, elevated temperatures, or chemical contact; however, the source of exposure remains unknown.Users are trained to inspect for signs of damage prior to and during use, and any product exhibiting damage should not be used.Information for safety is provided in the product labeling to ensure users are aware of potential risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the available information and product analysis, the cause of the strain relief degradation could not be determined; however, it is potentially related to the manufacturing process of the unit.An investigation has been initiated to further review the potential causes, and no further action 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: 22507074
• Report Number: 9616099-2025-01117
• Device Sequence Number: 8736674
• Product Code: DQO
• UDI-Device Identifier: 10705032012041
• UDI-Public: (01)10705032012041(17)260531(10)18218613
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 532598C
• Device Lot Number: 18218613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 10/08/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/12/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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