MAUDE Adverse Event Report: CORDIS CORPORATION CATH INF .038 F4 100 JR-4; DIAGNOSTIC CARDIOLOGY CATHETER (DQO)

Catalog Number 538421

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2014

Event Type  Injury  

Event Description

As reported by the affiliate, it was reported by the physician that the white radiopaque tip of the 4f catheter separated and is currently left in the patient's radial artery.The patient is currently in stable condition and is fine.The intended procedure was a coronary angiogram.For the procedure, an infiniti catheter was opened.There were no damages or anomalies noted to the device packaging prior to use or after the device was removed from the package.There were no anomalies noted during prep and the device was not resterilized.The catheter was inserted into the hemostasis valve of the sheath and inserted it into the right radial artery.The vessel was not calcified and the catheter was located in the radial loop.There was no stenosis rate and it was not a cto.However, during advancement to the target lesion, the radiopaque distal tip of the catheter separated.Resistance was not met when the catheter was being advanced into the patient and excessive torquing was not required.The device had not kinked/bent at location of separation.There was no resistance met while withdrawing the device.

Manufacturer Narrative

The separated tip segment migrated from area of separation and is currently residing in a small interosseous artery.The tip was not retrieved.An ir and vascular surgeon were consulted and they advised conservative treatment and to leave it alone.The patient is currently in stable condition and is fine.The catheter will be returned; however, the tip is still implanted.The product is available for analysis, however, it has not yet been received.A device history record (dhr) and additional information are pending and will be submitted within 30 days upon receipt.Please note that the gender of the patient is unknown.(b)(6).

Manufacturer Narrative

Please note that the device has been received for analysis; and was updated accordingly.However, the engineering report is not yet available and it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.A procedural film review was received and the following information was reported: observations: a brief clinical report and single cd-rom containing a single cine file are submitted for review.As per clinical report, the product looked fine prior to use and was prepped and used according to the ifu.The radial artery was not calcified and there was no apparent stenosis.As per the treating physician, resistance was not met while attempting to advance the catheter and excessive torquing was not necessary.After tip separation, the fragment traveled into the interosseous artery where is currently remains.The single cine image submitted shows catheter access in the radial artery.The catheter has been advanced to the level of the proximal forearm.The guide wire curves beyond the bifurcation and extends into the location of the interosseous artery rather than into the brachial artery where you would expect it to go.Normally the guide wire and catheter should go retrograde into the brachial artery.There is clearly an unsuccessful attempt to advance the catheter as the catheter begins to bow slightly and the catheter tip starts to curl.This suggests significant resistance was encountered.The tip of the catheter appears to be close to, or within, the interosseous artery.When the guide wire is removed, the tip of the catheter detaches and travels with blood flow distally; presumably into the more distal interosseous artery.Unfortunately, no contrast images are provided for this review.Angiogram images would be useful to evaluate the regional arteries.Was there stenosis of the radial or brachial arteries? was there anatomical variation? importantly, we could evaluate whether there was vasospasm or arterial dissection.Clearly the guide wire and catheter were not coursing in the correct retrograde direction and it is important to understand why that occurred.Conclusion: this complaint involves a 4 fr.Infiniti catheter which had the radio opaque tip separate and embolize during a radial artery access coronary angiogram.From the limited information and images provided it is difficult to fully evaluate this complaint.It is imperative to understand what the catheterized artery looked like at the time of the event.Contrast images would show the target vessel, anatomical variations, stenosis, dissection, and vasospasm.Clearly there was resistance met while trying to advance the guide wire and catheter into the brachial artery and why this occurred needs to be understood.Angiogram images, if available, would likely help elucidate the etiology of this event.I would be happy to continue my analysis if these images are made available.I cannot determine definitively whether or not a manufacturing defect of the catheter contributed to this event from the information provided.It is certainly not excluded at this point.As per report, the catheter has been returned for bench top analysis.This may help determine if a product defect was an issue.

Manufacturer Narrative

A procedural film was received and review of the film is pending.The product has not yet been received for analysis.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: it was reported by the physician that the white radiopaque tip of the 4f catheter separated and is currently left in the patient's radial artery.The patient is currently in stable condition and is fine.The intended procedure was a coronary angiogram.For the procedure, an infiniti diagnostic catheter was opened.There were no damages or anomalies noted to the device packaging prior to use or after the device was removed from the package.There were no anomalies noted during prep and the device was not resterilized.The catheter was inserted into the hemostasis valve of the sheath and inserted it into the right radial artery.The vessel was not calcified and the catheter was located in the radial loop.There was no stenosis and it was not a chronic total occlusion (cto).However, during advancement to the target lesion, the radiopaque distal tip of the catheter separated.Resistance was not met when the catheter was being advanced into the patient and excessive torquing was not required.The device had not kinked/bent at location of separation.There was no resistance met while withdrawing the device.The separated tip segment migrated from area of separation and is currently residing in a small interosseous artery.The tip was not retrieved.An interventional radiologist and a vascular surgeon were consulted and they advised conservative treatment.The patient is currently in stable condition and is fine.The tip remains implanted.Procedural films were received and forwarded for review by an independent physician.The film review notes; ¿from the limited information and images provided it is difficult to fully evaluate this complaint.It is imperative to understand what the catheterized artery looked like at the time of the event.Contrast images would show the target vessel, anatomical variations, stenosis, dissection, and vasospasm.Clearly there was resistance met while trying to advance the guide wire and catheter into the brachial artery and why this occurred needs to be understood.Angiogram images, if available, would likely help elucidate the etiology of this event.¿ the catheter was returned for analysis.A non-sterile 4f infiniti jr 4 100cm diagnostic catheter was returned for analysis.Per visual analysis, a separation was noted on the catheter at intermediate tip to tip fusion.Microscopic analysis revealed the separation end looks elongated and remains of the distal tip can be observed on the intermediate tip.Sem analysis revealed that the body tip surface presented evidence of transfer material and elongation at the surroundings areas of the separation.Functional analysis pull test was not performed as the product was incomplete.A device history record (dhr) review of lot 17045538 revealed no anomalies or non-conformances that can be associated with the reported event.According to the instructions for use (ifu); ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.Treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ the event reported by the customer as ¿brite tip/distal tip-separated-in patient¿ was confirmed due to the condition of the product returned.The exact cause of the separated condition could not be conclusively determined during analysis.Elongation is a common characteristic of pieces which were stretched and/or pulled until separation.Stretching and/or pulling could have been related to these separation characteristics.Neither the dhr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken.

• Brand Name: CATH INF .038 F4 100 JR-4
• Type of Device: DIAGNOSTIC CARDIOLOGY CATHETER (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4317979
• MDR Text Key: 5247777
• Report Number: 9616099-2014-00791
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 538421
• Device Lot Number: 17045538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability