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

Catalog Number	501814RMC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion as reported, an issue occurred during loading of a 5mm angioguard embolic capture guidewire (ecgw) system prior to the procedure and the device failed.A non-cordis embolic protection device was used to complete the procedure.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device prior to use.Upon opening the package, the deployment sheath tip was not fully seated in the filter basket introducer.Additional details were requested but were not provided.A non-sterile 5mm basket, medium support, angioguard rx for us carotid was received in a clear plastic bag, including the delivery sheath, the torquing device, and the ecgw system inserted into the delivery sheath; the remaining components were not returned.Visual evaluation showed the filter basket was deployed (expanded) and the guidewire exhibited a kink approximately 89 cm from the distal tip, with a second kink observed approximately 21 cm from the proximal end; no other notable observations were found.Vision-system inspection confirmed the kinked condition of the filter basket, and the membrane walls and distal tip showed no damage.Functional analysis could not be performed because the components needed for docking the filter basket were not returned.Visual evaluation further confirmed the filter basket was deployed, the guidewire was kinked, the filter basket was kinked, and the membrane walls and distal tip had no damage.While an investigation addressing a similar issue is active, no definitive evidence links this event to that investigation because the affected component was not returned.The reported ¿delivery system ¿ loading (docking) difficulty ¿ through introducer¿ could not be substantiated because one of the affected components was not returned (filter basket introducer).However, the malfunction ¿filter basket ¿ kinked/bent¿ was found during the product evaluation.The exact cause of the reported event cannot be found.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), although not intended as a mitigation of risk, ¿caution: guidewires are delicate instruments and should be handled carefully.Prior to use, and when possible, during the procedure, inspect the guidewire carefully for coil separation, bends, kinks, or damage of the filter basket assembly.Do not use defective equipment.¿ based on the information provided, the reported condition appears to be potentially manufacturing-related.However, no definitive evidence links this event to that investigation because functional analysis could not be performed.The event will be trended for surveillance purposes with no further actions taken at this time.
Event or Problem Description
As reported, an issue occurred during loading of a 5mm angioguard embolic capture guidewire (ecgw) system prior to the procedure and the device failed.A non-cordis embolic protection device was used to complete the procedure.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device prior to use.Upon opening the package, the deployment sheath tip was not fully seated in the filter basket introducer.Additional details were requested but were not provided.The device will be returned for evaluation.Addendum: product evaluation revealed that the filter basket is kinked.

• 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: 23639316
• Report Number: 1016427-2025-00090
• Device Sequence Number: 18456320
• Product Code: NTE
• UDI-Device Identifier: 10705032054805
• UDI-Public: (01)10705032054805(17)260930(10)35271926
• 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
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 501814RMC
• Device Lot Number: 35271926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: SPIDER DEVICE
• Patient Sex: Unknown