MAUDE Adverse Event Report: CORDIS US CORP. 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 02/29/2024

Event Type  malfunction  

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, the calibration markers on the 5f 110cm super torque marker band pigtail catheter moved during measurement and could not be used for accurate measurements.There was no reported patient injury.The device is expected to be returned for evaluation.

Event Description

Additional event details were requested; however, not provided.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.

Manufacturer Narrative

As reported, the calibration markers on the 5f 110cm super torque marker band pigtail catheter moved during measurement and could not be used for accurate measurements.There was no reported patient injury.One sterile cath mb 5f pig 110cm 6sh was received for analysis.During visual analysis, marker bands 4,9,10,11,12,13,14,15,16,17,18,19,20 were observed to be displaced from the expected manufacturing position.All 20 marker bands were present on the catheter body.(the position of the marker bands are numerated from the proximal portion to the distal end).Inner diameter (id) and outer diameter (od) measurements were taken in the area located between the assigned places for markers bands that are offset/out of position and were found out of specification.This condition was due to the out of position marker bands compressing the body, which has the internal and outside diameter remaining in a reduced state.Longitudinal measurements were found above the expected parameters, which presented evidence of elongations.A high magnification analysis to the surface of the marker bands did not present evidence of damage (scratches, peelings, abrasions, etc.).The reported ¿marker band (supertorque mb) ¿ offset/out of position - prior to/during measurement¿ was confirmed.The catheter elongation resulted in id/od reduction and subsequent marker band migration.While the exact cause of the elongation is unknown, 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 preventive or corrective actions will be taken at this time.

• Brand Name: SUPER TORQUE MB
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 18987975
• MDR Text Key: 338761483
• Report Number: 9616099-2024-00089
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2024

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 Operator: Health Professional
• Device Catalogue Number: 532598B
• Device Lot Number: 18265363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: Not provided; 05/15/2024
• Supplement Dates FDA Received: 04/19/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• 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