MAUDE Adverse Event Report: CORDIS US. CORP PRECISE PRO RX OUS; STENT, CAROTID

Catalog Number	PC0730XCE
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 7mm x 30mm precise pro carotid self-expanding stent (ses) delivery system jammed when opened.There was an indication that the stent was partially deployed inside the patient and could not be released.Afterwords, the entire stent was released outside of the patient.Subsequently, a new 7mm x 30mm precise pro carotid ses delivery system was used as a replacement.There were no reported injuries to the patient.The intended lesion was carotid artery stenting (cas).At the target site, there was no calcification, mild tortuosity, 70% stenosis, an acute angle, no bifurcation, and no chronic total occlusion (cto).The device was stored and prepared according to the instructions for use (ifu), and there was no damage to the device prior to use.The stent delivery system (sds) was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.During deployment, the user maintained a fixed inner shaft position and did not apply excess force.There was no difficulty removing the delivery system from the patient.The device will be returned for evaluation.

• Brand Name: PRECISE PRO RX OUS
• Common Device Name: STENT, CAROTID
• 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 ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 25042741
• Report Number: 9616099-2026-00595
• Device Sequence Number: 13172420
• Product Code: NIM
• UDI-Device Identifier: 20705032062388
• UDI-Public: (01)20705032062388(17)260331(10)18312394
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: PC0730XCE
• Device Lot Number: 18312394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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: 7MM X 30MM PRECISE PRO CAROTID SES DELIVERY SYSTEM.
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 66 KG