MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC ZILIENT

Model Number	30G-300-018
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A zilient guide wire was unable to cross a calcified lesion.The wire was completely unbraided.The patient was stable.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
A zilient guide wire was unable to cross a calcified lesion.The wire was completely unbraided.The patient was stable.
Additional Manufacturer Narrative
Correction to a previously submitted mdr: 3006010712-2023-00049.Brand name: csi,30g 300-018 to zilient.Manufacturer name: lake region medical to cardiovascular systems, inc.
Event or Problem Description
A zilient guide wire was unable to cross a calcified lesion.The wire was completely unbraided.The patient was stable.

• Brand Name: ZILIENT
• Common Device Name: ZILIENT
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC; parkmore west business park; galway, H91CK 22,; EI H91CK22,
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC; parkmore west business park; galway; galway, H91CK 22,; EI H91CK22,
• Manufacturer Contact: amy carter ; parkmore west business park; galway, H91 C- K22 ; EI H91 C K22
• MDR Report Key: 17868859
• Report Number: 3006010712-2023-00049
• Device Sequence Number: 5493743
• Product Code: DQX
• UDI-Device Identifier: 10852528005602
• UDI-Public: 10852528005602
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 30G-300-018
• Device Catalogue Number: 7-10050-08 REV E
• Device Lot Number: 6512337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023; Not provided
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/10/2023; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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