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 08/22/2023

Event Type  malfunction  

Event Description

As reported, the marker rings slid out of the packaging of the 5f 110cm 6 side holes (sh) super torque pigtail marker band (mb) angiographic catheter.The marker bands were still on the catheter, they only "remove" the position.The catheter was not inserted in the patient afterwards.Another super torque was used to complete the procedure.Procedural details were not provided.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no visible signs of device/packaging damage prior to use or anomalies noted when the device was taken out of the package nor excessive force 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 caused a condition that required hospitalization or significant prolongation of existing hospitalization.Two device pictures were provided for review.The device is expected to be returned for evaluation.

Manufacturer Narrative

A product history record (phr) review of lot 18102378 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.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 marker rings slid out of the packaging of the 5f 110cm 6 side holes (sh) super torque pigtail marker band (mb) angiographic catheter.The marker bands were still on the catheter, they only "remove" the position.The catheter was not inserted in the patient afterwards.Another super torque was used to complete the procedure.Procedural details were not provided.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no visible signs of device/packaging damage prior to use or anomalies noted when the device was taken out of the package nor excessive force 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 caused a condition that required hospitalization or significant prolongation of existing hospitalization.A unit of catheter cath mb 5f pig 110cm 6sh was returned for evaluation.During visual inspection, marker bands 18, 19, and 20 were observed out of position.Inner diameter (id) and outer diameter (od) measurements were taken in the area located between the intended marker band locations and found out of specification.This condition was caused by the offset marker bands compressing the body/shaft, which reduced the id and od of the catheter in these areas.Functional analysis was performed by inserting a lab sample guidewire inside the catheter via the distal tip.The guidewire would not pass through the entire catheter body.It became stuck when it reached the first marker band that was out of position.This was caused by the offset marker bands compressing the body/shaft which reduced the id.The unit was inspected with a vision system and no evidence of damage was noted (scratches, peeling, abrasions, etc.).A product history record (phr) review of lot 18102378 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band (super torque mb) ~offset/out of position-prior to/during measurement¿ was confirmed.Three marker bands were found out of position.The exact cause of the reported event could not be determined during the analysis.However, stretching/elongating the catheter while removing the device from the mounting card is a likely cause.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, ¿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.Do not use if the package is open or damaged.¿ 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 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: 17929896
• MDR Text Key: 325580952
• Report Number: 9616099-2023-06610
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)250331(10)18102378
• 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
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• 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: 18102378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2022
• 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
• Treatment: N/A.