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

Catalog Number 532598B

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/06/2023

Event Type  Injury  

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 5f 6 side holes (sh) 110cm super torque marker band (mb) pigtail catheter ruptured during endovascular surgery.A lasso was used to extract it.A second pigtail catheter of the same reference and batch was used to finish the procedure and also ruptured, requiring the use of a lasso.The intended procedure was reported to be an aortic endoprosthesis.The target lesion was the aorta.The device was not used for a chronic total occlusion (cto).The products were stored, handled, inspected, and prepped according to the instructions for use (ifu).Additional details were requested; however have not yet been provided.The devices are expected to be returned for analysis.Report (b)(4) was filed with the competent authority by submitter.

Manufacturer Narrative

As reported, a 5f 6 side holes (sh) 110cm super torque marker band (mb) pigtail catheter ruptured during endovascular surgery.A lasso was used to extract it.A second pigtail catheter of the same reference and batch was used to finish the procedure and ruptured, requiring the use of a lasso.The intended procedure was reported to be an aortic endoprosthesis.The target lesion was the aorta.The device was not used for a chronic total occlusion (cto).The products were stored, handled, inspected, and prepped according to the instructions for use (ifu).Without the return of the devices or images for analysis, the reported customer event ¿catheter (body/shaft)-separated¿ could not be confirmed for either event.Procedural factors resulting in the elongation and subsequent separation of the catheter may be contributing factors.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

The devices were not returned for evaluation.

Manufacturer Narrative

As reported, a 5f 6 side holes (sh) 110cm super torque marker band (mb) pigtail catheter ruptured during endovascular surgery.A lasso was used to extract it.A second pigtail catheter of the same reference and batch was used to finish the procedure and also ruptured, requiring the use of a lasso.The intended procedure was reported to be an aortic endoprosthesis.The target lesion was the aorta.The device was not used for a chronic total occlusion (cto).The products were stored, handled, inspected, and prepped according to the instructions for use (ifu).Two non-sterile cath mb 5f pig 110cm 6sh units were received for analysis.The first unit was analyzed under 04523-1 and the second unit was analyzed under 04523-2.04523-1.During visual analysis, a separated condition was observed on the body of the catheter.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.A high magnification visual analysis was performed along the border of the separation and plastic deformation such as elongation patterns were observed.No further analysis using higher magnification equipment was required as the observed findings presented evidence of a possible inadequate mechanical interaction with the received unit.The reported ¿catheter (body/shaft) ¿ separated¿ was confirmed for both devices.The elongation patterns suggest an excessive tensile strength was applied to the catheter, which may be attributed to the separation.Additionally, the scratch marks observed on the second returned device may be from an interaction between the catheter and a sharp-edged material.Procedural factors such as entrapment of the catheter between endovascular devices and the vessel wall (as suggested by scratch marks) 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 available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

Event Description

The device was returned for evaluation.

Manufacturer Narrative

The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

• 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 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18297517
• MDR Text Key: 330114061
• Report Number: 9616099-2023-06658
• Device Sequence Number: 1
• Product Code: DQO
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532598B
• Device Lot Number: 18225225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2023
• 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
• Patient Outcome(s): Required Intervention