MAUDE Adverse Event Report: CORDIS CORPORATION RX/5MM BASKET DIAMETER/180CM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Catalog Number 501814RE

Device Problem Retraction Problem (1536)

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

Event Date 08/28/2022

Event Type  malfunction  

Manufacturer Narrative

This is one of two products involved with the reported event and the associated manufacturer report number is: 1016427-2022-05422.A review of the manufacturing documentation associated with lot 35265344 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during the use of a 5mm 180cm angioguard rx embolic capture guidewire (ecgw) system, it was not possible to advance the capture system over the angioguard to recapture the device.As a result, the capture sheath could not be used, and a new 5mm 180cm angioguard rx ecgw system was opened in order to use its capture sheath to remove the first 5mm angioguard device.However, the capture sheath for the second 5mm angioguard device was also unable to advance over the first 5mm angioguard device.Therefore, a 6f non-cordis guiding catheter was used and was able to advance over the initially deployed 5mm angioguard, through a previously deployed stent to successfully recapture the distal protection of the 5mm angioguard.There was no reported injury to the patient.Both devices were inspected, stored, and prepped per the instructions for use (ifu) and there was nothing unusual about either device prior to use.The first 5mm angioguard device was deployed without issue, and there were no reported separations on either device.Information regarding the patient, target lesion characteristics, flushing of the device, and the removal of the first 5mm angioguard was requested but was not provided.The device will be returned for evaluation.

Manufacturer Narrative

This is one of two products involved with the reported event and the associated manufacturer report number is: 1016427-2022-05422.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

This is one of two products involved with the reported event and the associated manufacturer report number is: 1016427-2022-05422.Complaint conclusion: during the use of a 5mm 180cm angioguard rx embolic capture guidewire (ecgw) system, it was not possible to advance the capture system over the angioguard to recapture the device.As a result, the capture sheath could not be used, and a new 5mm 180cm angioguard rx ecgw system was opened in order to use its capture sheath to remove the first 5mm angioguard device.However, the capture sheath for the second 5mm angioguard device was also unable to advance over the first 5mm angioguard device.Therefore, a 6f non-cordis guiding catheter was used and was able to advance over the initially deployed 5mm angioguard, through a previously deployed stent to successfully recapture the distal protection of the 5mm angioguard.There was no reported injury to the patient.Both devices were inspected, stored, and prepped per the instructions for use (ifu) and there was nothing unusual about either device prior to use.The first 5mm angioguard device was deployed without issue, and there were no reported separations on either device.Information regarding the patient, target lesion characteristics, flushing of the device, and the removal of the first 5mm angioguard was requested but was not provided.The products were returned for analysis.One non-sterile rx/5mm basket diameter/180cm unit was received coiled for analysis inside a plastic bag.Per visual analysis, the capture sheath and the ecgw were returned for evaluation.No anomalies were observed on the components during the analysis.Per functional analysis the capture sheath advanced over the ecgw returned for analysis and capture the filter basket with no difficulty or resistance/friction.A product history record (phr) review of lot 35265344 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿capture sheath ¿ resistance/friction - inner lumen¿ and ¿capture system - capture difficulty - unable to¿ were not confirmed by analysis of the returned devices as functional analysis was performed successfully.The exact cause of the reported event could not be determined.Procedural and/or handling factors might have contributed to the reported event since the device did not present any indication of manufacturing defect or anomaly that could contribute to the event as reported.According to the instructions for use, which are not intended as a mitigation of risk, ¿capture sheath ¿ after the interventional or diagnostic procedure is completed, attach a 10-ml luer lock syringe to flushing luer hub.Flush with 10 ml of sterile saline.The entire coil dispenser should be filled with saline.Remove the syringe from the flushing luer hub.Do not remove the capture sheath from the coil dispenser until required system retrieval.Note: never attempt to capture the filter basket with the deployment sheath.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.Remove the device by grasping the guidewire and capture sheath together near the hemovalve.Pull the system through the guiding catheter or interventional sheath introducer, and out of the hemovalve as a single unit.Care should be taken when pulling the basket through the open hemovalve, to avoid potential release of captured emboli.¿ the devices performed as intended and therefore the reported event and the phr could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: RX/5MM BASKET DIAMETER/180CM
• 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 NH 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15478618
• MDR Text Key: 301128608
• Report Number: 1016427-2022-05423
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 10705032054775
• UDI-Public: (01)10705032054775(17)240430(10)35265344
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Catalogue Number: 501814RE
• Device Lot Number: 35265344
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/29/2022; 10/24/2022
• Supplement Dates FDA Received: 10/24/2022; 10/27/2022
• 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: 6F BENCHMARK GUIDING CATHETER (PENUMBRA).