MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598B

Device Problems Partial Blockage (1065); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2017

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported, the super torque marker catheter became blocked during the positioning maneuver.A withdrawal maneuver was performed in order to unlock it, but the catheter broke off leaving a piece within the aorta.Consequently, another catheter was used to remove it.The product will not be returned for analysis.Multiple attempts to gather additional information have been made and have been unsuccessful.The device was not returned for analysis.A device history record (dhr) review could not be conducted as a lot number was not provided.The reported ¿catheter (body/shaft) obstructed - in-patient¿ and ¿catheter (body/shaft) separated - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the obstruction and separation could not be determined.Based on the limited information available for review, procedural/handling factors (withdrawal maneuver to unlock catheter) may have contributed to the reported event as separation reported.It is unknown what factors may have ¿blocked¿ the catheter since further explanation of the issue was not provided; however, procedural/handling factors are likely.According to the instructions for use, which is not intended as a mitigation, ¿failure to observe these instructions may result in damage, breakage or separation of the catheter or the markerbands, which may necessitate additional intervention.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.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.Avoid excessive friction on the catheter; avoid simultaneous introduction of the catheter and aortic graft devices through the same sheath.Prior to using the device, inspect for bends, kinks or other damage.Advance the catheter to the desired position in the vasculature.To prevent kinking of the catheter, ensure that the pigtail catheter is not straightened by hand, but only with a diagnostic guidewire.Avoid excessive tension on the device during manipulation.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm super torque® mb angiographic catheter positioning under high quality fluoroscopic observation.¿ without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.

Event Description

As reported, the super torque marker catheter became blocked during the positioning maneuver.A withdrawal maneuver was performed in order to unlock it, but the catheter broke off leaving a piece within the aorta.Consequently, another catheter was used to remove it.The product will not be returned for analysis.Multiple attempts to gather additional information have been made and have been unsuccessful.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6888635
• MDR Text Key: 87159128
• Report Number: 9616099-2017-01447
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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