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

Catalog Number 601814RE

Device Problems Device Difficult to Setup or Prepare (1487); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

During a carotid angioplasty, while preparing the 6mm angioguard rx embolic protection device, the filter did not enter the delivery sheath.The procedure was completed successfully without patient injury using another angioguard.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was nothing unusual noted about the device prior to use.The percentage of stenosis was eighty percent and the device was not used for a chronic total occlusion.The lesion was not pre-dilated.Upon opening the package, the deployment sheath tip was not fully seated in the filter basket introducer.It was attempted to be to manually inserted into the filter basket introducer and failed.There was no difficulty encountered flushing the filter introducer and deployment sheath.Saline was noted within the coil dispenser at the green deployment sheath hub.The torque device was locked onto the guidewire.The anti-migration clip located closest to the filter introducer was left in place while the filter basket was being attempted to be docked into the deployment sheath.The capture sheath coil dispenser was flushed according to the ifu.There was filter basket deformation noted.The hemostatic valve was fully opened prior to the insertion of the angioguard.No other information was provided.The device was not returned for analysis.A product history record (phr) review of lot 35234397 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The events reported as ¿delivery system~loading (docking) difficulty - into delivery sheath¿ and ¿filter basket~out of shape¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural/handling factors may have contributed to the reported events.As per the instructions for use (ifu), which is not intended as a mitigation ¿remove the two anti-migration clips closest to torque device and pull to ensure torque device is securely attached to guidewire.Gripping the torque device in one hand and the coil dispenser in the other, pull on the wire until the basket is completely docked into the tip of the deployment sheath.When completely docked, approximately half the filter basket will still be visible out the end of the deployment sheath.Remove the last anti-migration clip.Open the torque device.Gripping the torque device in one hand and the proximal end of the guidewire in the other, pull the wire through the torque device until the proximal end of the deployment sheath hub engages the torque nut.Lock the torque device onto the guidewire; ensure the deployment sheath hub remains engaged with the torque nut.Pull the wire and deployment sheath out of dispenser coil.¿ the phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, while preparing the 6mm angiogard rx embolic protection device, it was not possible to encapsulate the filter inside the catheter.After several attempts following the products standard, the filter did not enter the sheath.No patient injury was reported.The intended procedure was a carotid angioplasty.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The device prepped normally and there was nothing unusual noted about the device prior to use.The device was stored in the distributor and was sent to the cath lab at the moment of the surgery.The percentage of stenosis was eighty percent and the device was not used for a chronic total occlusion.The lesion was not pre-dilated.Upon opening the package, the deployment sheath tip was not fully seated in the filter basket introducer.It was attempted to be to manually inserted into the filter basket introducer and failed.There was no difficulty encountered flushing the filter introducer and deployment sheath.Saline was noted within the coil dispenser at the green deployment sheath hub.The torque device was locked onto the guidewire.The anti-migration clip located closest to the filter introducer was left in place until after the filter basket was docked into the deployment sheath.The capture sheath coil dispenser was flushed according to the ifu.There was filter basket deformation.The hemostatic valve was fully opened prior to the insertion of the angioguard.The procedure was completed successfully without patient injury using another angioguard.

Manufacturer Narrative

While preparing a 6mm angiogard rx embolic protection device, it was not possible to encapsulate the filter inside the catheter.After several attempts following the products standard, the filter did not enter the sheath.No patient injury was reported.The intended procedure was a carotid angioplasty.The percentage of stenosis was 80% and the device was not used for a chronic total occlusion.The lesion was not pre-dilated.Upon opening the package, the deployment sheath tip was not fully seated in the filter basket introducer.It was attempted to be manually inserted into the filter basket introducer but failed.There was no difficulty encountered flushing the filter introducer and the deployment sheath.Saline was noted within the coil dispenser at the green deployment sheath hub.The torque device was locked onto the guidewire.The anti-migration clip located closest to the filter introducer was left in place until after the filter basket was docked into the deployment sheath.The capture sheath coil dispenser was flushed according to the instructions for use (ifu).There was noted filter basket deformation.The hemostatic valve was fully opened prior to the insertion of the angioguard.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The device prepped normally and there was nothing unusual noted about the device prior to use.The device was stored in the distributor and was sent to the cath lab at the moment of the surgery.The procedure was completed successfully using another angioguard.The product was returned for analysis.A non-sterile unit of a ¿angioguard rx 6mm 180cm¿ was received inside of a clear plastic bag.The components include the delivery sheath and the embolic capture guidewire (ecgw) system.The rest of the parts were not returned for analysis.Per visual analysis the ecgw system was noted to be inserted into the delivery sheath and the filter basket was deployed.A 6 cm, unzipped condition was observed on the delivery sheath located at 32 cm from the distal end.No other damages or anomalies were noted.The functional analysis was not performed due to the unzipped condition on the delivery sheath.Per microscopic analysis, no anomalies or damages were observed neither on the filter struts nor on the membrane walls.A product history record (phr) review of lot 35234397 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter basket out of shape¿ was not confirmed, the filter did not present any anomalies or damages.The reported ¿delivery system - loading (docking) difficulty into delivery sheath¿ was confirmed, as an unzipped condition was observed on the deployment sheath.The exact cause of the observed condition could not be conclusively determined during analysis.Vessel characteristics of 80% stenosis and not pre-dilating the lesion may have contributed to the reported event.Additionally, procedural and or handling factors might have contributed to the reported events.According to the instructions for use, which is not intended as a mitigation of risk ¿prior to the interventional procedure, all equipment and packaging, including the angioguard rx emboli capture guidewire system, should be inspected and examined carefully for defects.Check guidewire, filter basket, deployment sheath, capture sheath, and capture sheath rx port region (approximately 30 cm from the distal tip) for bends, kinks, or other damage.Do not use defective equipment.Load the capture sheath over the proximal end of the angioguard rx emboli capture guidewire.Grasp the guidewire proximally as it exits the rx port and advance the capture sheath through the open hemostasis valve.Continue to advance the capture sheath until the distal capture sheath marker band is adjacent to the proximal filter basket marker band.This collapses the filter basket.Using fluoroscopy, confirm filter basket closure by ensuring reduction of diameter of the radiopaque strut marker bands.Note: the emboli that have been captured may not allow the angioguard rx emboli capture guidewire to reach its initial low profile.Open the hemostasis valve to allow the angioguard rx emboli capture guidewire free movement and reduce the likelihood of damage during removal.Remove the device by simultaneously pulling the guidewire and capture sheath through the guiding catheter or interventional sheath introducer, and out of the hemostasis valve as a single unit.Care should be taken when pulling the basket through the open hemostasis valve, to avoid potential release of captured emboli.¿ neither the product analysis nor the phr review suggests that the event experienced by the customer is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken 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
• MDR Report Key: 8153339
• MDR Text Key: 130048905
• Report Number: 9616099-2018-02577
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K062531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 601814RE
• Device Lot Number: 35234397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANGIOGUARD; UNKNOWN CATHETER; UNKNOWN SHEATH
• Patient Age: 70 YR
• Patient Weight: 80