MAUDE Adverse Event Report: CORDIS CORPORATION VISTA BRITE TIP GUIDING CATHETERS; CARDIOLOGY GUIDING CATHETERS (DQY)

Catalog Number 67005400

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).This device is available for analysis but has not yet been received.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.

Event Description

It was reported that prior to a percutaneous coronary artery stenting procedure, upon opening a vista brite tip guiding catheter, the device was folded double in the shape part of the catheter and it was not used.A second device with the same catalog and lot number was used instead via radial access to address an occluded lad, it twisted or folded double in the shape part of the device.There was difficulty removing the device and the patient was in serious pain during removal of the device.The patient was treated with morphine for the pain and after a vascular consult, it was determined that the patient had no vessel damage.The procedure was aborted and the patient would have another vascular follow up to assess the access site.When they opened it up the first device (the same code, shape, and lot number), the physician saw that it was twisted or folded double in the shape part and this catheter could not be used.They pulled another guiding catheter.He checked the catheter, it seemed fine, there was no kink and he advanced it into patient.The size and brand of guidewire was used in the procedure was a "035 wire cook/marcus medical.The guiding catheter was prepped per the ifu and there was no difficulty experienced in prepping the device.There was no difficulty tracking through the vasculature and no excessive force used during advancement.When they came to (root) point where he needs to torque catheter to find the coronary, the catheter kinked at the same place where the other one was kinked before they used it.He tried to straighten the wire kink with all safe options, even an micro-catheter.It would not go through the kink.He cut it at the back to try to insert a micro catheter in effort to try and straighten out the kink.So after trying all safe possibilities, to straighten it, and it wouldn't, he pulled it back as is, through the arm (where it caused the immense pain and possible damage).He tried to pulled as much of it as possible into sheath.The kinked shape of the catheter would not pull into sheath.So the doctor removed the sheath first and then removed the catheter, with its kinked tip, through the access site, as this was the only way it would remove.He did an immediate doppler test to determine artery condition and found pulse.He treated the patient immediately with morphine.The patient was immediately sent to a vascular surgeon.No portion of the device remained in the patient.Vascular surgeons were reportedly happy with pulse they do find but still determining damage to artery.They did not complete the stent of lad.Irrespective from this incident, the condition of heart was determined that stenting of lad would not make improvement.The patient was sent to vascular surgeons, who did doppler test that evening and again in the morning to determine vessel condition.The vessel proved to be fine.The patient is also booked by vascular surgeons for later this week to do final assessment.In the patient's arm there was a pulse, seems good, they are assessing it in a week's time from yesterday.The access site itself is fine.The current status of the patient seems good.

Manufacturer Narrative

Additional information was received that this patient¿s pulse was perfect when he left hospital and no complications was left due to product kinking.No additional information is available and no further reports will be forthcoming.

Manufacturer Narrative

It was reported that prior to a percutaneous coronary artery stenting procedure, upon opening a vista brite tip guiding catheter, the device was folded in the curvature of the catheter and it was not used.A second device with the same catalog and lot number was used instead via the radial access to address an occluded left anterior descending (lad) coronary artery; it also folded in the curvature of the device.There was difficulty removing the device and the patient was in serious pain during removal of the device.The patient was treated with morphine for the pain.After a vascular consult, it was determined that the patient had no vessel damage.Upon receipt of the device, the distal tip of one of the devices was noted to be separated.The distal tip was not included.Additional details of how the tip separated could not be obtained.He stated he does not exactly know when it separated, but all was removed from the patient after a battle.The procedure was aborted and the patient would have another vascular follow up to assess the access site.When they opened up the first device, the physician saw that it was twisted or folded double in the shape part and this catheter could not be used.They pulled another guiding catheter, which was noted to not have any damages, and the physician advanced it into patient.The size and brand of guidewire that was used in the procedure was a ¿.035 wire cook/marcus medical.¿ the guiding catheter was prepped per the instructions for use (ifu) and there was no difficulty experienced in prepping the device.There was no difficulty tracking through the vasculature and no excessive force used during advancement.When they came to the point where he needs to torque the catheter to find the coronary ostium, the catheter kinked at the same place where the other one was kinked before they used it.He tried to straighten the kink with the wire but was unsuccessful.He cut it at the back to try to insert a micro catheter in effort to try and straighten out the kink.So after trying all safe possibilities to straighten it and it wouldn¿t, he pulled it back as is through the arm (where it caused the immense pain and possible damage).He tried to pulled as much of it as possible into sheath.The kinked shape of the catheter would not pull into sheath.So the doctor removed the sheath first and then removed the catheter, with its kinked tip, through the access site, as this was the only way it could be removed.He did an immediate doppler test to determine the condition of the artery and found a pulse.He treated the patient immediately with morphine.The patient was immediately sent to a vascular surgeon.No portion of the device remained in the patient.Vascular surgeons were reportedly satisfied with the pulse they found but still wanted to determine damage to the artery.They did not complete the stent of the lad.Irrespective from this incident, the condition of heart was determined that stenting of lad would not make improvement.The patient was sent to vascular surgeons, who did doppler testing that evening and again in the morning to determine vessel condition.The vessel proved to be fine.The patient is also booked by vascular surgeons for a follow up final assessment.The access site itself is fine.The current status of the patient seems good.Two non-sterile units of vista brite tip 6f.070 were received coiled inside a plastic bag.The kinked catheter was analyzed under (b)(6) and the separated catheter will be analyzed under this pi.Per the visual analysis of the catheter received that will be analyzed under this product analysis, a kinked condition was found at 55.6cm from id band as well as a catheter body separation was found at 97.5cm from id band (at distal section) and the separated part was not received for analysis.The separated section of received catheter was inspected under microscope and elongations were observed.Also, scanning electron microscope (sem) analysis was performed to the catheter in order to identify the source of the body separated condition.The results are the following: ¿results showed that the separated section of the catheter body presented elongations.The elongations observed presented evidence of a plastic deformation as a product of an application of a tension force that induced the separation.Also the braid wire presented evidence ductile dimples.Ductile dimples can suggests pulling / stretching events.No other anomalies found during sem analysis.¿ functional analysis could not be performed since the catheter was received separated at the distal end.The catheter od and id were measured near the separated and kinked conditions.All measurements were found within specification.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.The complaint reported by the customer ¿catheter (body/shaft) - kinked/bent¿ was confirmed by the condition of the received product.However, the cause of the kinked conditions found through the catheters body could not be conclusively determined during the analysis.Controls are in place to verify the catheters for kinked conditions and damages on the guiding catheters.Product analysis and dhr review results do not suggest that these kinked conditions are related to the manufacturing process.Procedural factors, handling and storage process may have contributed to the kinked conditions found.The complaint reported by the customer ¿catheter (body/shaft) - withdrawal difficulty-through sheath¿ could not be confirmed since functional analysis could not be performed due to the separation found at catheter distal end.This event reported by the customer could be related to the kinked condition found on the catheter body.Additionally, the device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported, so this issue is not considered related to the manufacturing process.The complaint reported by the customer as ¿catheter (body/shaft) - separated-in patient¿ was confirmed based on the condition the catheter was received.The exact cause of the catheter body separation could not be conclusively determined during the analysis.Based on the information available for review, procedural factors (stretching or pulling) may have contributed to the separation as evidenced by elongations and ductile dimples noted during analysis.According to the product instructions for use, manipulation of the catheter under excessive friction can lead to stretching or elongation of the catheter.Neither the dhr nor the product analysis suggests that the reported event could be related to the design or manufacturing process.Therefore no corrective or preventative actions will be taken.

Manufacturer Narrative

The device was received and preliminary evaluation indicates "kinks throughout.Distal tip on one detached and not included.Additional details of how the tip separated could not be obtained.Additional follow up indicated in the prior report the physician "tried to straighten it with the wire.It would not go through the kink.He cut it at the back to try insert a micro catheter in effort to try and straighten out the kink.¿ he also stated he cannot exactly know when he cut it, but all was removed.Further details regarding the missing distal tip were not provided.(b)(4).The completed analysis will be submitted within 30 days upon receipt.

• Brand Name: VISTA BRITE TIP GUIDING CATHETERS
• Type of Device: CARDIOLOGY GUIDING CATHETERS (DQY)
• 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: 5004722
• MDR Text Key: 23089894
• Report Number: 9616099-2015-00368
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 67005400
• Device Lot Number: 17148314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention