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

Catalog Number 532598C

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

As reported, a 5f 65cm 8-sidehole (sh) super torque mb angiographic catheter broke near the markers while on the amplatz wire.The procedure time was prolonged "while patient was intubated at critical procedure time".There were no reports of patient injury.The device was returned for evaluation.

Manufacturer Narrative

-as the sterile lot number was not available, device history record review could not be performed.-this device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.-additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a 5f 65cm 8-sidehole (sh) super torque mb angiographic catheter broke near the markers while on an amplatz wire.The procedure time was prolonged "while patient was intubated at a critical procedure time".There were no reports of patient injury.One unit of catheter cath mb 5f pig 65cm 8sh was received for evaluation.During visual inspection, the catheter was noted to be separated into two parts at 25 cm from the distal tip.No other damages or anomalies were observed on the returned device.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis was not performed because the damages associated with the separation are visible with the magnification obtained with a vision system.Vision system analysis of both separated edges presented evidence of elongations on the plastic and plastic deformation.A product history record (phr) review could not be performed because the lot number for this product is unknown.The complaint reported by the customer as ¿catheter (body/shaft)-separated¿ was confirmed.The catheter was received separated into two parts.The elongations on the plastic and plastic deformations are commonly associated with separations caused by material tensile/twist overload.Therefore, it is assumed that the material was induced to a tensile/twist forces that exceeded the material yield strength prior to the separation.Handling factors such as manipulating the catheter under excessive friction 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, ¿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.

• 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: 17712326
• MDR Text Key: 322979634
• Report Number: 9616099-2023-06593
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2023
• 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