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

Catalog Number	533552
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone (b)(6).Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, luer lock of the cordis f5.2+ jr4 100cm super torque angiographic catheter had a defect with potential leakage.There was no reported injury to the patient.The returned devices were taken from the shelf by the clinic staff themselves.The returned devices are still freshly packaged.These are still in their packaging.The devices have not unpacked or tested to see if they also have any damage or leakage.Unfortunately, we did not receive the products that were actually affected.Additional information was not received after multiple attempts.
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, luer lock of the cordis f5.2+ jr4 100cm super torque angiographic catheter had a defect with potential leakage.There was no reported injury to the patient.The returned devices were taken from the shelf by the clinic staff themselves.The returned devices are still freshly packaged.These are still in their packaging.The devices have not unpacked or tested to see if they also have any damage or leakage.Unfortunately, we did not receive the products that were actually affected.Additional information was not received after multiple attempts.
Event or Problem Description
As reported, luer lock of the cordis f5.2+ jr4 100cm super torque angiographic catheter had a defect with potential leakage.There was no reported injury to the patient.The returned devices were taken from the shelf by the clinic staff themselves.The returned devices are still freshly packaged.These are still in their packaging.The devices have not unpacked or tested to see if they also have any damage or leakage.Unfortunately, we did not receive the products that were actually affected.Additional information was not received after multiple attempts.
Additional Manufacturer Narrative
As reported, luer lock of the cordis f5.2+ jr4 100cm super torque angiographic catheter had a defect with potential leakage.There was no reported injury to the patient.The returned devices were taken from the shelf by the clinic staff themselves.The returned devices are still freshly packaged.They are still in their packaging and have not been tested to see if they also have any damage or leakage.Unfortunately, we did not receive the products that were affected.Additional information was not received after multiple attempts.Forty-three unused cath f5.2+ jr4 100cm devices from lot (18330164) and catalog number (533552), were received for evaluation.These devices were returned in their sealed inner packages and original box.The devices were unpacked to proceed with the product evaluation.Per procedure, the sample size resulted in a 100% inspection of all received units.During the visual inspection, all units were reviewed, and the devices were checked for any damage or anomalies in the luer hub that could have contributed to the reported failure.No damage or anomalies were observed on the luer hubs of the returned devices.All 43 catheters were flushed and no leaks were noted from the hub of any of the returned devices.Microscopic analysis and amplified imaging were performed on all received units, and no damage or leaks were observed on the hub of any of the devices.Without the return of the device or images for analysis, the reported customer event ¿luer hub-leakage¿ could not be confirmed for the affected device.Additionally, all 43 of the unaffected devices showed no signs of damages or leakage to the luer hub.Storage or handling factors may have contributed to the reported event.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 to make 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, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: SUPER TORQUE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue 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: 20818191
• Report Number: 9616099-2024-00454
• Device Sequence Number: 7683301
• Product Code: DQO
• UDI-Device Identifier: 10705032012676
• UDI-Public: (01)10705032012676(17)270531(10)18330164
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 533552
• Device Lot Number: 18330164
• Was Device Available for Evaluation?: Yes
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/18/2024; 01/21/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/13/2025; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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