MAUDE Adverse Event Report: LAKE REGION MEDICAL CRUISER-18, MED, 300-018

Model Number	357261
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the physician deliver the guidewire to pass the lesion, but the tip of the guidewire was broken and stuck in the lesion, since the vessel had already blocked, the physician did not try to archive the broken tip, the patient was stable.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
During the procedure, the physician deliver the guidewire to pass the lesion, but the tip of the guidewire was broken and stuck in the lesion, since the vessel had already blocked, the physician did not try to archive the broken tip, the patient was stable.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.

• Brand Name: CRUISER-18, MED, 300-018
• Common Device Name: CRUISER-18, MED, 300-018
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer Contact: krishna priya ; parkmore west business park; galway
• MDR Report Key: 17682505
• Report Number: 3006010712-2023-00045
• Device Sequence Number: 19472566
• Product Code: DQX
• UDI-Device Identifier: 07640130442726
• UDI-Public: 07640130442726
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102211
• 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
• Report Date (Section B): 09/26/2023

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: 06/30/2025
• Device Model Number: 357261
• Device Catalogue Number: 357261
• Device Lot Number: 7337615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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