MAUDE Adverse Event Report: CORDIS CORPORATION ANGIOGUARD RX 6.00MM 180; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 601814RE

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2022

Event Type  Injury  

Manufacturer Narrative

The product history review is expected but has not been completed.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.

Event Description

As reported, when using a 6.00mm 180 angioguard rx emboli capture guidewire the connection between the umbrella body (filter basket) and the guidewire was broken which resulted in the umbrella not being recovered.The filter separated during retrieval.The filter was recovered with an unknown 8f large diameter guiding catheter.There was no reported patient injury.The device was inspected and prepped according to the instruction for use (ifu) and there was nothing unusual about the device prior to use.This was during a carotid artery stenting (cas) procedure.There was no difficulty encountered while advancing the device towards the lesion.There were no issues deploying the filter.An image review was completed for the two images attached and the first image shows the angioguard filter placed in the carotid artery, apparently below the bifurcation of the internal and external carotid arteries.The device markers can be clearly observed, and the distal tip appears intact.The second image shows the device removed from the body, bloodstained and possibly containing debris within the filter basket.The capture sheath is over the wire, but the filter basket is no longer constrained.The distal tip appears intact, and the filter appears attached to the guidewire.No anomalies noted.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d4, g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: when using a 6.00mm 180cm angioguard rx emboli capture guidewire the connection between the umbrella body (filter basket) and the guidewire was broken which resulted in the umbrella not being recovered.The filter separated during retrieval.The filter was recovered with an unknown 8f large diameter guiding catheter.There was no reported patient injury.The device was inspected and prepped according to the instruction for use (ifu) and there was nothing unusual about the device prior to use.This was during a carotid artery stenting (cas) procedure.There was no difficulty encountered while advancing the device towards the lesion.There were no issues deploying the filter.The product was not returned for analysis.One non-sterile unit of catheter angioguard rx 6.00mm 180cm was received coiled inside of a clear plastic bag.Per visual analysis the ecgw (already captured), and the capture sheath were returned for evaluation, no anomalies nor damages were noted during analysis on the components returned.A product history record (phr) review of lot 35265342 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿ecgw (embolic capture guidewire) fractured/separated - in-patient¿ was not confirmed by analysis of the returned device as the device was received with neither damages nor anomalies.The exact cause of the reported event could not be determined.According to the instructions for use, which are not intended as a mitigation of risk, ¿guidewires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guidewire carefully for coil separation, bends, kinks, or damage of the filter basket assembly.Once the lesion is treated and all of the interventional or diagnostic devices have been removed, remove the flushed capture sheath from the dispenser coil and thread over the proximal end of the guidewire.Grasp the guidewire proximally as it exits the rx port and push the capture sheath through the open hemostasis valve.Collapse the filter basket by advancing the capture sheath until the distal capture sheath marker band is adjacent to the proximal filter basket marker band.Using fluoroscopy, confirm filter basket closure by ensuring reduction of diameter of the radiopaque strut marker bands.Note: do not try removing the angioguard rx emboli capture guidewire by only pulling on the capture sheath.Note: never pull the angioguard rx emboli capture guidewire into the guiding catheter or interventional sheath introducer if there is resistance.If resistance is encountered, reposition the capture sheath to ensure that the filter basket is properly seated into the capture sheath.Using fluoroscopy, verify capture sheath position by checking marker band alignment between the capture sheath and the guidewire.¿ the device appears to have performed as intended and therefore the reported event could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time at this time.

Manufacturer Narrative

Corrected data section h6 corrected & updated complaint conclusion below: when using a 6.00mm 180cm angioguard rx emboli capture guidewire the connection between the umbrella body (filter basket) and the guidewire was broken which resulted in the umbrella not being recovered.The filter separated during retrieval.The filter was recovered with an unknown 8f large diameter guiding catheter.There was no reported patient injury.The device was inspected and prepped according to the instruction for use (ifu) and there was nothing unusual about the device prior to use.This was during a carotid artery stenting (cas) procedure.There was no difficulty encountered while advancing the device towards the lesion.There were no issues deploying the filter.The product was not returned for analysis.One non-sterile unit of catheter angioguard rx 6.00mm 180cm was received coiled inside of a clear plastic bag.Per visual analysis the ecgw (already captured), and the capture sheath were returned for evaluation, no anomalies nor damages were noted during analysis on the components returned.A picture of the device was provided for review, which showed no anomalies.A product history record (phr) review of lot 35265342 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿ecgw (embolic capture guidewire) fractured/separated - in-patient¿ was not confirmed by analysis of the returned device as the device was received with neither damages nor anomalies.Additionally, the picture analysis does not show any damage on the unit.The exact cause of the reported event could not be determined.According to the instructions for use, which are not intended as a mitigation of risk, ¿guidewires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guidewire carefully for coil separation, bends, kinks, or damage of the filter basket assembly.Once the lesion is treated and all of the interventional or diagnostic devices have been removed, remove the flushed capture sheath from the dispenser coil and thread over the proximal end of the guidewire.Grasp the guidewire proximally as it exits the rx port and push the capture sheath through the open hemostasis valve.Collapse the filter basket by advancing the capture sheath until the distal capture sheath marker band is adjacent to the proximal filter basket marker band.Using fluoroscopy, confirm filter basket closure by ensuring reduction of diameter of the radiopaque strut marker bands.Note: do not try removing the angioguard rx emboli capture guidewire by only pulling on the capture sheath.Note: never pull the angioguard rx emboli capture guidewire into the guiding catheter or interventional sheath introducer if there is resistance.If resistance is encountered, reposition the capture sheath to ensure that the filter basket is properly seated into the capture sheath.Using fluoroscopy, verify capture sheath position by checking marker band alignment between the capture sheath and the guidewire.¿ the device appears to have performed as intended and therefore the reported event could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time at this time.

• Brand Name: ANGIOGUARD RX 6.00MM 180
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• 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 ; 7863138372
• MDR Report Key: 15946777
• MDR Text Key: 305142118
• Report Number: 1016427-2022-05432
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 10705032056717
• UDI-Public: (01)10705032056717(17)240430(10)35265342
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062531
• 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
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 601814RE
• Device Catalogue Number: 601814RE
• Device Lot Number: 35265342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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
• Treatment: UNKNOWN 8F LARGE DIAMETER GUIDING CATHETER
• Patient Outcome(s): Life Threatening