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

Model Number 601814RE

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

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

Event Date 08/10/2021

Event Type  malfunction  

Event Description

As reported, during the insertion of the angioguard rx 6.00mm 180 filter, the guide was met tortuosity at the end.When removing the filter, it opened making it impossible to remove or reinsert it.The device is expected to be returned for evaluation.

Manufacturer Narrative

(b)(4).This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Lot number corrected from 35234258 to 35238248 per additional information received.Manufacturing and expiration dates added.

Manufacturer Narrative

Complaint conclusion: during the insertion of the angioguard rx 6.00mm 180 filter, the guide was met tortuosity at the end.When removing the filter, it opened making it impossible to remove or reinsert it.The device was not returned for analysis.A product history record (phr) review of lot 35238248 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.Without the return of the device for analysis and based on the information provided, the reported ¿capture system withdrawal difficulty unable to¿, ¿capture system re-deployment¿ and ¿delivery system tracking difficulty¿ were not confirmed.Procedural and or handling factors such as vessel characteristics (although unknown) and the user¿s interaction with the device during the recovery process may have led to the reported event.According to the instructions for use ¿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 phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• 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 60th ave; miami lakes FL 03246
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13338506
• MDR Text Key: 287330698
• Report Number: 1016427-2022-05389
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K062531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 601814RE
• Device Catalogue Number: 601814RE
• Device Lot Number: 35238248
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2019
• 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: UNK GUIDE DEVICE.