MAUDE Adverse Event Report: CORDIS US CORP. ANGIOGUARD RX; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Catalog Number	801814RMC
Medical Device Problem Codes	Stretched (1601); Increase in Suction (1604)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, with all migration clips removed on the 8mm angioguard, the device was having issues being removed from the hoop.A different device had to be opened and used.There was no reported injury to the patient.The device was opened and prepped per instructions for use (ifu).The device was prepper per the instructions for use (ifu).The physician had extreme difficulty removing the device.A new angioguard device was used to complete the procedure.Addendum: the pe results presented the distal tip (ecgw)-unraveled/stretched.
Additional Manufacturer Narrative
As reported, with all migration clips removed on the 8mm angioguard, the device was having issues being removed from the hoop.A different device had to be opened and used.There was no reported injury to the patient.The device was opened and prepped per instructions for use (ifu).The device was prepper per the instructions for use (ifu).The physician had extreme difficulty removing the device.A new angioguard device was used to complete the procedure.The 8mm basket, medium support, angioguard rx for us carotid was returned inside a clear plastic bag and evaluated.The returned components included the deployment sheath, filter, and filter introducer, while the remainder of the system was not returned.The device was received inserted inside the deployment sheath.Visual analysis identified a buckling condition on the delivery sheath located approximately 26 to 30 cm from the distal tip, and the distal tip of the ecgw system was observed to be kinked and unraveled.No other notable observations were identified on the returned components.Microscopic analysis confirmed the kinked and unraveled condition of the distal tip using a vision system, and inspection of the filter basket area showed that the struts and membrane filter did not exhibit damage or anomalies.Functional analysis related to removal difficulty from the dispenser was not performed because the coil dispenser was not returned.The evaluation did not identify evidence to suggest the reported event is related to the manufacturing or design process, and no further actions are planned based on the available information.The reported ¿packaging/pouch/box ¿ removal difficulty system from dispenser¿ could not be substantiated because the coil dispenser was not returned.However, the malfunction ¿distal tip (ecgw) ¿ unraveled/stretched¿ was observed.The exact cause of the event cannot be determined and use related factors cannot be excluded.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), 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.Based on the available information, there is no evidence to suggest the reported event is related to manufacturing or design issues.Therefore, no additional actions will be taken.

• Brand Name: ANGIOGUARD RX
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 340 lake hazeltine drive; chaska, minnesota 55318 ; 7863138372
• MDR Report Key: 24674972
• Report Number: 1016427-2026-00022
• Device Sequence Number: 18695764
• Product Code: NTE
• UDI-Device Identifier: 10705032056946
• UDI-Public: 10705032056946
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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 Catalogue Number: 801814RMC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMBOLIC PROTECTION DEVICE
• Patient Sex: Unknown