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

Model Number 532598B

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, it was impossible to remove the super torque marker catheter (cath mb 5f pig 110cm 6sh) from the lunderquist guide.There was strong resistance met.When trying to remove the catheter, it broke into the introducer, leaving the tip inside the patient left iliac artery (20cm).Using a lasso system, the broken piece was removed from the patient artery, without any injuries for the patient.The product was clinically used and will be returned for analysis.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, it was impossible to remove the super torque marker catheter (cath mb 5f pig 110cm 6sh) from the lunderquist guide.There was strong resistance met.When trying to remove the catheter, it broke into the introducer, leaving the tip inside the patient left iliac artery (20cm).Using a lasso system, the broken piece was removed from the patient artery, without any injuries for the patient.The product was clinically used and will be returned for analysis.The intended procedure was an angiography process.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted when the device was removed from the packaging.There was no difficulty in removing the device from the packaging.The device was prepped per the ifu.There were no kinks nor other damages noted prior to inserting the product the product into the patient.The other devices used with the product did not kink nor bend at any time.The product, or any of the other devices used with it, had not been resterilized.There was no difficulty crossing the lesion.

Manufacturer Narrative

Complaint conclusion: as reported, it was impossible to remove the supertorque markerband catheter (cath mb 5f pig 110cm 6sh) from the lunderquist guide.There was strong resistance met.When trying to remove the catheter, it broke into the introducer, leaving the tip inside the patient left iliac artery (20cm).Using a lasso system, the broken piece was removed from the patient artery, without any injuries for the patient.The intended procedure was an angiography process.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted when the device was removed from the packaging.There was no difficulty in removing the device from the packaging.The device was prepped per the ifu.There were no kinks nor other damages noted prior to inserting the product the product into the patient.The other devices used with the product did not kink nor bend at any time.The product, or any of the other devices used with it, had not been resterilized.There was no difficulty crossing the lesion.One non-sterile unit of cath mb 5f pig 110cm 6sh was received coiled inside a plastic bag.Per visual analysis, the catheter tip was found separated at 24.5cm from catheter¿s distal end.All the marker bands were observed in its correct position.No other anomalies were observed on the received product.Functional test was performed by advancing a 0.038¿ lab sample guidewire through both catheter sections, and no resistance was experienced during the wire¿s insertion\withdrawal.The catheter¿s id/od were measured near the separated conditions and results were found within specification.The separated catheter body was sent to sem analysis, and the results showed that the catheter¿s separated areas presented material deformation and evidence of elongations.The elongations observed suggests that the device was induced to stretching/pulling events that exceeded the material¿s yield strength prior to the separation.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 17642162 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported ¿brite tip/distal tip separated in patient¿ was confirmed through analysis of the returned device.However, the cause of the separated tip condition could not be conclusively determined during the analysis.The reported ¿catheter (body/shaft) resistance/friction inner lumen¿ was not confirmed for the returned device since functional and dimensional analysis were performed successfully.Based on the limited information available for review, handling factors (removing the catheter with strong resistance) most likely contributed to the catheter tip separation as evidenced by the material deformation and elongations at the separated area noted during sem analysis.As warned and cautioned in the ifu, 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.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.¿ neither the dhr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• 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 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6912295
• MDR Text Key: 88124791
• Report Number: 9616099-2017-01483
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17642162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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
• Patient Weight: 80