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	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5mm angioguard filter basket did not fully withdraw into the deployment sheath hub, which may have sheared the porous membrane when withdrawn through the hoop.Upon removal from the hoop, the device tip was inspected and appeared to have pieces of the filter exposed in a way that indicated the device was unfit for safe utility.The device was discarded without use, and a second angioguard was prepped deployed as intended.There was no reported injury to the patient.The device was prepped by the physician.The device will be returned for evaluation.
Event or Problem Description
As reported, a 5mm angioguard filter basket did not fully withdraw into the deployment sheath hub, which may have sheared the porous membrane when withdrawn through the hoop.Upon removal from the hoop, the device tip was inspected and appeared to have pieces of the filter exposed in a way that indicated the device was unfit for safe utility.The device was never advanced once this observation was made.The device was discarded without use, and a second angioguard was prepped deployed as intended.There was no reported injury to the patient.The device was prepped by the physician.The device was discarded after it was noted that the membrane was "irregular and exposed".
Additional Manufacturer Narrative
As reported, a 5mm angioguard filter basket did not fully withdraw into the deployment sheath hub, which may have sheared the porous membrane when withdrawn through the hoop.Upon removal from the hoop, the device tip was inspected and appeared to have pieces of the filter exposed in a way that indicated the device was unfit for safe utility.The device was never advanced once this observation was made.The device was discarded without use, and a second angioguard was prepped deployed as intended.There was no reported injury to the patient.The device was prepped by the physician.It was noted that the membrane was "irregular and exposed".The product was not returned for analysis.A review of the manufacturing documentation associated with lot 35271836 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis and based on the limited images provided, the reported customer complaint ¿filter basket kinked/bent and delivery system loading (docking) difficulty into delivery sheath¿ could not be evaluated.Without the return of the device the exact cause of the reported event could not be determined.Unspecified procedural, handling, and/or anatomical factors may have contributed to the reported issue.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 to make 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.¿ per the instruction for use (ifu) while 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.While 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 the dispenser coil.The deployment sheath is now prepped and ready for use.Based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no preventative or corrective actions will be taken at this time.

• 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: 22979834
• Report Number: 1016427-2025-00075
• Device Sequence Number: 8937915
• Product Code: NTE
• UDI-Device Identifier: 10705032054805
• UDI-Public: (01)10705032054805(17)260831(10)35271836
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 08/31/2026
• Device Catalogue Number: 501814RMC
• Device Lot Number: 35271836
• Was Device Available for Evaluation?: No
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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: ANOTHER DEVICE.
• Patient Sex: Unknown