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

Catalog Number	501814RMC
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the physician while prepping the device could not load the filter of a 5mm angioguard rx embolic protection device.The device was not used in the patient.Another angioguard was used and the filter successfully loaded.There was no reported patient injury.The device was stored as per labeling and was opened in sterile field.There were no visible signs of device or package damage prior to use.Upon opening the package, the deployment sheath tip was not fully seated in the filter basket introducer and was manually inserted.No difficulty was encountered while flushing the filter introducer and deployment sheath.The torque device was locked onto the guidewire, and the capture sheath coil dispenser was flushed according to the instructions for use (ifu).The anti-migration clip located closest to the filter introducer was not applicable in this case.While docking the filter basket into the deployment sheath, some difficulty was encountered.It is noted that when properly docked, approximately half of the filter basket remains visible out of the end of the deployment sheath.The non-sterile ¿5mm basket, medium support, angioguard rx for us carotid¿ was received inside a clear plastic bag containing the delivery sheath with the ecgw system inserted.Other components were not returned.Visual evaluation revealed the filter over-docked and stuck inside the delivery sheath, a kink in the guidewire on the proximal section, partial peeling of the delivery sheath, and a kinked and unraveled distal tip of the ecgw system.Functional analysis confirmed the filter was unable to deploy due to being stuck inside the sheath.No additional damages were observed, and dimensional analysis was not performed beyond ruler measurements to preserve device condition.The evaluation did not provide evidence that the observed anomalies were related to manufacturing or design processes.The reported malfunction ¿delivery system ¿ loading (docking) difficulty¿ could not be substantiated because the filter basket introducer associated with the event was not returned.The malfunctions ¿distal tip (ecgw) ¿ unraveled/stretched¿ and ¿delivery system ¿ deployment difficulty ¿ unable¿ were discovered during the product evaluation.The exact cause of the event cannot be determined.Information for safety is provided in the product¿s 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, ¿do not use the device if there are abnormalities in the sterile barrier (e.G.Broken seal, torn or breached barrier) or product.¿ and ¿caution: the deployment and capture sheaths are delicate instruments and should be handled carefully.Prior to use, and when possible during the procedure, inspect the 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.¿ and ¿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.¿ the decision to discontinue use of the device aligns with the device labeling.Based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, the physician while prepping the device could not load the filter of a 5mm angioguard rx embolic protection device.The device was not used in the patient.Another angioguard was used and the filter successfully loaded.There was no reported patient injury.The device was stored as per labeling and was opened in sterile field.There were no visible signs of device or package damage prior to use.Upon opening the package, the deployment sheath tip was not fully seated in the filter basket introducer and was manually inserted.No difficulty was encountered while flushing the filter introducer and deployment sheath.The torque device was locked onto the guidewire, and the capture sheath coil dispenser was flushed according to the instructions for use (ifu).The anti-migration clip located closest to the filter introducer was not applicable in this case.While docking the filter basket into the deployment sheath, some difficulty was encountered.It is noted that when properly docked, approximately half of the filter basket remains visible out of the end of the deployment sheath.The device was returned for evaluation.

• Brand Name: ANGIOGUARD RX
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 340 lake hazeltine drive; chaska, minnesota 55318 ; 7863138372
• MDR Report Key: 23102225
• Report Number: 1016427-2025-00079
• Device Sequence Number: 8686091
• 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): 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): 09/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 501814RMC
• Device Lot Number: 35271836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• 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: 09/15/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 79 YR
• Patient Sex: Male