MAUDE Adverse Event Report: CORDIS CORPORATION 4MM BASKET, MEDIUM SUPPORT,; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 401814RMC

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/28/2021

Event Type  malfunction  

Manufacturer Narrative

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.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, the filter basket of a.014¿ 4mm x 180cm angioguard rapid exchange (rx) medium support emboli capture guidewire system was opened and kinked before it came out of hoop even after prepped properly.There was no reported patient injury.The intended procedure was a left carotid angioplasty and stenting (cas).The product was received in this condition.The product was stored normally and handled according to the instructions for use (ifu).There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The integrity of the sterile pouch was not compromised.A new device was used to complete the procedure.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: the filter basket of an angioguard rapid exchange (rx).014¿ 4mm x 180cm medium support emboli capture guidewire system was opened and kinked before it came out of hoop even after prepped properly.The intended procedure was a left carotid angioplasty and stenting (cas).The product was received in this condition.The product was stored normally and handled according to the instructions for use (ifu).There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The integrity of the sterile pouch was not compromised.A new device was used to complete the procedure.There was no reported patient injury.The device was returned for analysis.One non-sterile units of an angioguard ¿4mm basket, medium support,¿ was received inside of a clear plastic bag.The device was unpacked from the pouch in order to perform the product evaluation.The components returned included on the shipping were one delivery sheath with the ecgw system and the torquing device.The rest of the parts were not returned for analysis.The filter basket was received in a deployed condition.No anomalies were noted on the device.The filter basket area was magnified with a vision system to perform the evaluation.As a result of this inspection, no anomalies or damages were observed neither on the filter struts nor on the membrane walls.A product history record (phr) review of lot 35262199 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter basket- kinked/bent - during prep¿ was not confirmed, since no anomalies were noted on the device.The exact cause of the observed condition could not be conclusively determined during the analysis.It is difficult to draw a clinical conclusion between the device and the event based on the information available.Based on the product analysis, the filter basket presented no anomalies and therefore, it is probable that the user may have prepped the device incorrectly.According to the instructions for use, which is not intended as a mitigation of risk ¿the package contains two plastic coil dispensers.One contains the guidewire with filter basket, filter basket introducer, peel away guidewire introducer, torque device, and black/yellow deployment sheath.The second contains the blue capture sheath, which will not be needed until the filter basket is ready to be removed from the vessel.During shipping the deployment sheath tip may become disengaged from the filter basket introducer.Verify deployment sheath tip is engaged.If not, engage manually by inserting deployment sheath tip into filter basket introducer.Fill a 10-ml luer lock syringe with sterile saline and purge all air from syringe.Attach syringe to luer lock hub on the end of the filter basket introducer.Inject 10 ml of saline to purge all air from the deployment sheath and filter basket (ensure distal tip of the deployment sheath is engaged with the filter basket introducer tip prior to purging the system).You may see saline dripping along the length of the deployment sheath.Flushing is complete when saline is seen within coil dispenser at the green deployment sheath hub.Disconnect syringe.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 deployment sheath is now prepped and ready for use.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: 4MM BASKET, MEDIUM SUPPORT,
• 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: 11705101
• MDR Text Key: 247758487
• Report Number: 9616099-2021-04452
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 401814RMC
• Device Catalogue Number: 401814RMC
• Device Lot Number: 35262199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.