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

Catalog Number	601814RMC
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The peel away sheath of the angioguard would not completely peel away, it would kink and pull the basket back.The only issue with the device was the peel-away introducer portion not fully peeling away.There was no reported injury to the patient.Device was prepped by the dr as per ifu (instructions for use).The device looked fine as did the others that have failed.Package was stored properly on a shelf in the or with no damage visible to package.A cordis stent was placed across the carotid stenosis with no problems after the peel-away introducer failed and had to be ¿walked off the wire¿.Additional information was requested; however, the information was not obtained.The product was not returned for analysis.A product history record (phr) review of lot 35269680 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿deployment (delivery) sheath peeling difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event.According to the instructions for use, which is not intended as a mitigation of risk ¿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.¿ neither the phr review nor the limited information provided suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, the peel away sheath of the angioguard would not completely peel away, it would kink and pull the basket back.The only issue with the device was the peel-away introducer portion not fully peeling away.There was no reported injury to the patient.Device was prepped by the dr as per ifu instructions.The device looked fine as did the others that have failed.Package was stored properly on a shelf in the or with no damage visible to package.A cordis stent was placed across the carotid stenosis with no problems after the peel-away introducer failed and had to be ¿walked off the wire¿.Additional information was requested; however, the information was not obtained.The device will not be returned for evaluation.

• 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: 17879707
• Report Number: 1016427-2023-05564
• Device Sequence Number: 7409595
• Product Code: NTE
• UDI-Device Identifier: 10705032056748
• UDI-Public: (01)10705032056748(17)250531(10)35269680
• 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): 10/05/2023

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: 05/31/2025
• Device Catalogue Number: 601814RMC
• Device Lot Number: 35269680
• 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: Not provided
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• 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 Sex: Unknown