MAUDE Adverse Event Report: CORDIS CORPORATION INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 534620T

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the distal end of a 6f tl judkin¿s left (jl) 4 x 100cm infiniti diagnostic catheter was found separated from the rest part of the catheter.It was separated into 2 parts.There were difficulties advancing and withdrawing the device.The separated catheter was taken out by capture device.This issue affected the safety of the operation, though there were no reports of patient injury.The operator of the device reported that there was no ¿violent rotation¿ during the operation.The device was used for a tortuous angiographic procedure.A contralateral approach was not used.The target site vessel was mildly calcified and moderately tortuous.It was 70% stenosed and had no acute angulation or bifurcation.The access site had the same characteristics of the target vessel site.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The user was trained in the use of the device.The device was stored and prepped in accordance with instructions for use (ifu).There were no damages found on the device or its packaging prior to use.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18120871 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.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

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the distal end of a 6f tl judkin¿s left (jl) 4 x 100cm infiniti diagnostic catheter was found separated from the rest part of the catheter.It was separated into 2 parts.There were difficulties advancing and withdrawing the device.The separated catheter was taken out by capture device.This issue affected the safety of the operation, though there were no reports of patient injury.The operator of the device reported that there was no ¿violent rotation¿ during the operation.The device was used for a tortuous angiographic procedure.A contralateral approach was not used.The target site vessel was mildly calcified and moderately tortuous.The access site was the radial artery.It was 70% stenosed and had no acute angulation or bifurcation.The access site had the same characteristics of the target vessel site.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The user was trained in the use of the device.The device was stored and prepped in accordance with instructions for use (ifu).There were no damages found on the device or its packaging prior to use.The physician did not attempt to change the shape of or alter the manufactured shape of the catheter.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the distal end of a 6f tl judkin¿s left (jl) 4 x 100cm infiniti diagnostic catheter was found separated from the rest part of the catheter.It was separated into 2 parts.There were difficulties advancing and withdrawing the device.The separated catheter was taken out by capture device.This issue affected the safety of the operation, though there were no reports of patient injury.The operator of the device reported that there was no ¿violent rotation¿ during the operation.The device was used for a tortuous angiographic procedure.A contralateral approach was not used.The target site vessel was mildly calcified and moderately tortuous.The access site was the radial artery.It was 70% stenosed and had no acute angulation or bifurcation.The access site had the same characteristics of the target vessel site.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The user was trained in the use of the device.The device was stored and prepped in accordance with instructions for use (ifu).There were no damages found on the device or its packaging prior to use.The physician did not attempt to change the shape of or alter the manufactured shape of the catheter.The device was returned for analysis.One non-sterile unit of a cath f6inf tl jl 4 100cm was received inside of a clear plastic bag.During the visual inspection, a kinked/bent condition was noted on the body/shaft located approximately at 85.8 cm from the strain relief.A separated condition was noted at the tip, near the fusion line, located approximately at 88.1 cm from the strain relief, the separated portion of the tip was not returned for analysis.The separated end was located approximately at 2 mm from the fusion line.No other anomalies in the hub nor body/shaft were noted.Dimensional analysis was performed at three distances along the body shaft and on the fusion line and the inner and outer diameters were found to be within specification.Sem analysis was performed and showed evidence of elongations in the area of the separation.The elongations found on the plastic material of the unit are commonly associated with separations caused by material tensile overload.The frontal view of the separated end presented no evidence of anomalies on the fusion of the components.No other anomalies were observed during the sem analysis.During visual inspection with the vision system, tooling marks or mechanical damages were noted near the separated end, these marks could be related to instruments used during procedure/handling of the unit.The phr review for lot 18120871 was reviewed and no issues were noted that could be related to the reported complaint.The reported ¿catheter (body/shaft) ¿ withdrawal difficulty¿ and ¿catheter (body/shaft) ¿ tracking difficulty¿ were not confirmed since due the nature of the complaint the event could not be properly evaluated.The reported ¿brite tip/distal tip ¿ separated¿ was confirmed since a separation was noted on the tip near the fusion line.While the exact cause for the event could not be definitively determined there are procedural and handling factors such as not keeping the device properly flushed during use or continuing to use the device when there is resistance in advancing the device.According to the instructions for use (ifu), although not intended as a mitigation of risk, use a guidewire when introducing the catheter through the catheter sheath introducer.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.Ptef coated guidewires are recommended for use with cordis angiographic catheters.The factors that contributed to the event reported remained undetermined at this point, the event has been escalated through the risk management process to further investigate the issue.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14021 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16881818
• MDR Text Key: 314708822
• Report Number: 9616099-2023-06486
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970854
• 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,Followup
• Report Date: 06/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 534620T
• Device Lot Number: 18120871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 73 KG