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

Catalog Number 532598C

Device Problem Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

As reported, the marker band slid along the 5f 110cm 8 side holes (sh) super torque pigtail marker band (mb) angiographic catheter during the intervention.The marker band did not fall off the device during use in the patient; it dislocated from the catheter and slid prior to measurement during use in the patient.All the marker bands were present on the catheter when removed from the patient.Another super torque was used to complete the procedure.There was no reported patient injury.The intended procedure was not provided.Access site and vessel characteristics at target site were not provided.The device was stored and handled per the instructions for use (ifu).The device was not exposed to a hot climate or room temperature.There were no visible signs of device/packaging damage prior to use or anomalies noted when the device was taken out of the package.No excessive force was applied to the device during withdrawal from the package.The event did not cause a clinically relevant increase in the duration of the procedure nor a condition that required hospitalization or significant prolongation of existing hospitalization.The device was discarded at site.A procedural cd or radiological report is not available for review.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the marker band slid along the 5f 110cm 8 side holes (sh) super torque pigtail marker band (mb) angiographic catheter during the intervention.The marker band did not fall off the device during use in the patient; it dislocated from the catheter and slid prior to measurement while inside the patient.All the marker bands were present on the catheter when removed from the patient.Another super torque was used to complete the procedure.There was no reported patient injury.The intended procedure was not provided.Access site and vessel characteristics at target site were not provided.The device was stored and handled per the instructions for use (ifu).The device was not exposed to a hot climate or room temperature.There were no visible signs of device/packaging damage prior to use or anomalies noted when the device was taken out of the package.No excessive force was applied to the device during withdrawal from the package.The event did not cause a clinically relevant increase in the duration of the procedure nor a condition that required hospitalization or significant prolongation of existing hospitalization.Without the return of the device or images for analysis, the reported customer event ¿marker band (super torque mb-offset/out of position-prior to/during measurement¿ could not be confirmed.Excessive manipulation of the catheter while the device was trapped in the patient¿s vasculature 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, ¿contraindications: do not use the super torque mb catheter in procedures where entrapment of the catheter between endovascular devices and the vessel wall may occur, for example endovascular aortic repair (evar) procedures.Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.¿ without the return of the device, the root cause could not be conclusively determined.However, an investigation to address marker band movement has already been initiated.No further action will be taken at this time.

Event Description

The device was discarded at site.A procedural cd or radiological report is not available for review.

• Brand Name: SUPER TORQUE MB
• Type of Device: 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: 17995363
• MDR Text Key: 326379638
• Report Number: 9616099-2023-06616
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012041
• UDI-Public: 10705032012041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532598C
• Device Lot Number: 18092733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1