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

Catalog Number	533621
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during a coronary angiogram, the f6 st+ jr 4 supertorque diagnostic catheter was found to not lock into manifold extension tubing resulting in inadequate and unsafe connection for intraarterial/intracoronary contrast injections.The damage was noticed upon connection prior to use.The cordis jr 4 100cm super torque plus was removed from procedure, a new cordis jr 4 100cm super torque plus was provided, it was found to connect adequately in order allow coronary angiogram to proceed.There was no reported injury to the patient.There was no damage to the packaging of the device.The product was stored in the lab by hanging on a hook with the provided hanging point.No anomalies were noted when the device was taken out of the package.The device was not pulled from the packaging by the hub, and no anomalies were noted at this time.The device was prepped per the ifu.No difficulty was experienced in prepping the device.The catheter was not advanced through the sheath, so there was no resistance or friction.No excess force was used during the case.The device was discarded.
Additional Manufacturer Narrative
As reported, during a coronary angiogram, the f6 st+ jr 4 supertorque diagnostic catheter was found to not lock into manifold extension tubing resulting in inadequate and unsafe connection for intraarterial/intracoronary contrast injections.The damage was noticed upon connection prior to use.The cordis jr 4 100cm super torque plus was removed from procedure, a new cordis jr 4 100cm super torque plus was provided, it was found to connect adequately in order allow coronary angiogram to proceed.There was no reported injury to the patient.There was no damage to the packaging of the device.The product was stored in the lab by hanging on a hook with the provided hanging point.No anomalies were noted when the device was taken out of the package.The device was not pulled from the packaging by the hub, and no anomalies were noted at this time.The device was prepped per the ifu.No difficulty was experienced in prepping the device.The catheter was not advanced through the sheath, so there was no resistance or friction.No excess force was used during the case.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18367064 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint " luer hub incompatibility/fit with injector tubing/iv tubing" could not be evaluated.With the limited information provided, without the return of the device, and with no procedural films, the cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy 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 open or damaged packages.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ based on the device history record review, 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.
Event or Problem Description
As reported, during a coronary angiogram, the f6 st+ jr 4 supertorque diagnostic catheter was found to not lock into manifold extension tubing resulting in inadequate and unsafe connection for intraarterial/intracoronary contrast injections.The damage was noticed upon connection prior to use.The cordis jr 4 100cm super torque plus was removed from procedure, a new cordis jr 4 100cm super torque plus was provided, it was found to connect adequately in order allow coronary angiogram to proceed.There was no reported injury to the patient.There was no damage to the packaging of the device.The product was stored in the lab by hanging on a hook with the provided hanging point.No anomalies were noted when the device was taken out of the package.The device was not pulled from the packaging by the hub, and no anomalies were noted at this time.The device was prepped per the ifu.No difficulty was experienced in prepping the device.The catheter was not advanced through the sheath, so there was no resistance or friction.No excess force was used during the case.The device was discarded.

• Brand Name: SUPER TORQUE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATON; 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: 21729777
• Report Number: 9616099-2025-00514
• Device Sequence Number: 4109164
• Product Code: DQO
• UDI-Device Identifier: 10705032013048
• UDI-Public: (01)10705032013048(17)280831(10)18367064
• 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
• Report Date (Section B): 04/22/2025

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: 533621
• Device Lot Number: 18367064
• Was Device Available for Evaluation?: No
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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
• Patient Sex: Unknown