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

Catalog Number 532598B

Device Problem Structural Problem (2506)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the gold marker bands on a 5f 110cm 6 side-hole super torque 20 marker band (mb) diagnostic catheter were very loose on the shaft of the device.Marker band movement was observed prior to/during measurement; however, all marker bands remained on the catheter.There were no reported injuries to the patient.This was during an endovascular aneurysm repair (evar) procedure.The super torque mb catheter was not jailed during the procedure.The device was stored and prepped per the instructions for use (ifu) and all marker bands were present and in their manufactured position when the device was opened and prepped.The device was not returned for evaluation.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 and the exact cause of the reported event could not be determined.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.¿ based on the information available and the phr 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 Description

As reported, the gold marker bands on a 5f 110cm 6 side-hole super torque 20 marker band (mb) diagnostic catheter were very loose on the shaft of the device.Marker band movement was observed prior to/during measurement; however, all marker bands remained on the catheter.There were no reported injuries to the patient.This was during an endovascular aneurysm repair (evar) procedure.The super torque mb catheter was not jailed during the procedure.The device was stored and prepped per the instructions for use (ifu) and all marker bands were present and in their manufactured position when the device was opened and prepped.The device will not be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the gold marker bands on a 5f 110cm 6 side-hole super torque 20 marker band (mb) diagnostic catheter were very loose on the shaft of the device.Marker band movement was observed prior to/during measurement; however, all marker bands remained on the catheter.There were no reported injuries to the patient.This was during an endovascular aneurysm repair (evar) procedure.The super torque mb catheter was not jailed during the procedure.The device was stored and prepped per the instructions for use (ifu) and all marker bands were present and in their manufactured position when the device was opened and prepped.The device was not returned for evaluation.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 and the exact cause of the reported event could not be determined.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.¿ based on the information available, 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 Description

As reported, the gold marker bands on a 5f 110cm 6 side-hole super torque 20 marker band (mb) diagnostic catheter were very loose on the shaft of the device.Marker band movement was observed prior to/during measurement; however, all marker bands remained on the catheter.There were no reported injuries to the patient.This was during an endovascular aneurysm repair (evar) procedure.The super torque mb catheter was not jailed during the procedure.The device was stored and prepped per the instructions for use (ifu) and all marker bands were present and in their manufactured position when the device was opened and prepped.The device will not be returned for evaluation.

• Brand Name: SUPER TORQUE MB
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 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: 18992794
• MDR Text Key: 339334674
• Report Number: 9616099-2024-00094
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: 10705032012034
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 532598B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 14F SHEATH