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

Catalog Number	532598B
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the proximal part of a 5f 110cm super torque marker band (mb) catheter broke off in blue pieces close to the hub.The device was not used in the patient.There was no reported patient injury.The condition was noticed after the device was received and stored in the lab while showing a student the difference in shapes.The device was stored and handled as per the instructions for use (ifu).The devices are stored in the lab hanging on storage hooks.The account requested to send back all catheters with that lot number (total of 5 additional catheters) although no issues were noted in those.The account wanted to pull those off the shelf.Pictures were received for review and show blue polymer flakes within the packaging that originate from the strain relief.The devices were returned.
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the proximal part of a 5f 110cm super torque marker band (mb) catheter broke off in blue pieces close to the hub.The device was not used in the patient.There was no reported patient injury.The condition was noticed after the device was received and stored in the lab while showing a student the difference in shapes.The device was stored and handled as per the instructions for use (ifu).The devices are stored in the lab hanging on storage hooks.The account requested to send back all catheters with that lot number (total of 5 more catheters) although no issues were noted in those.The account wanted to pull those off the shelf.Pictures were received for review and show blue polymer flakes within the packaging that originate from the strain relief.Six sterile units of the cath mb 5f pig 110cm 6sh catheter were received coiled inside a transparent plastic bag and unpacked for evaluation.Visual inspection revealed that one unit had a degraded strain relief, while no other visible damage or anomalies were seen on the returned components.Amplified imaging identified yellow discoloration on the hub and the presence of blue flakes from the degraded strain relief within the sealed package.Based on these findings, the complaint has been confirmed and is being escalated for further investigation.The reported ¿strain relief-degradation¿ was seen on one of the devices during the product analysis, which correlates with the reported events.The exact cause of the degradation is unknown.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, ¿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.Therefore, an investigation has been initiated to further review the potential causes.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 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 22020564
• Report Number: 9616099-2025-00823
• Device Sequence Number: 12967628
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)250930(10)18156880
• 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): 07/17/2025

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: 09/30/2025
• Device Catalogue Number: 532598B
• Device Lot Number: 18156880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 07/09/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/19/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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: N/A.
• Patient Sex: Unknown