MAUDE Adverse Event Report: LAKE REGION MEDICAL VICTORY 18 (300 CM, 18G)

Model Number	901023-24
Medical Device Problem Codes	Flaked (1246); Peeled/Delaminated (1454); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
As bsc rep was not present for the event, this is how the event was described: victory 18 wire was passed across multiple challenging lesions/calcific areas.Navicross crossing catheter was passed over the wire, and when victory 18 wire was pulled back for removal, the physician stated it felt as if something had let loose.Upon pulling the victory 18 wire out of the patient, it was noticed that the blue coating had come off the wire and was no longer present.Physician was concerned that the tip of the wire had come off inside the patient.It was decided then to remove the navicross crossing cath.And upon doing so, the blue coating was literally hanging from the tip of the navicross.Bsc rep's understanding is that the navicross was in fact an.018, so sizing here should not have been an issue.Sounds as if coating on the victory wire came off potentially after crossing multiple challenging lesions or difficult calcified areas.Bsc rep was not present during this procedure.
Event or Problem Description
As bsc rep was not present for the event, this is how the event was described: victory 18 wire was passed across multiple challenging lesions/calcific areas.Navicross crossing catheter was passed over the wire, and when victory 18 wire was pulled back for removal, the physician stated it felt as if something had let loose.Upon pulling the victory 18 wire out of the patient, it was noticed that the blue coating had come off the wire and was no longer present.Physician was concerned that the tip of the wire had come off inside the patient.It was decided then to remove the navicross crossing cath.And upon doing so, the blue coating was literally hanging from the tip of the navicross.Bsc rep's understanding is that the navicross was in fact an.018, so sizing here should not have been an issue.Sounds as if coating on the victory wire came off potentially after crossing multiple challenging lesions or difficult calcified areas.Bsc rep was not present during this procedure.
Additional Manufacturer Narrative
Complaint investigation report is attached to this report.
Additional Manufacturer Narrative
Complaint investigation report is attached to this report.
Event or Problem Description
As bsc rep was not present for the event, this is how the event was described: victory 18 wire was passed across multiple challenging lesions/calcific areas.Navicross crossing catheter was passed over the wire, and when victory 18 wire was pulled back for removal, the physician stated it felt as if something had let loose.Upon pulling the victory 18 wire out of the patient, it was noticed that the blue coating had come off the wire and was no longer present.Physician was concerned that the tip of the wire had come off inside the patient.It was decided then to remove the navicross crossing cath.And upon doing so, the blue coating was literally hanging from the tip of the navicross.Bsc rep's understanding is that the navicross was in fact an.018, so sizing here should not have been an issue.Sounds as if coating on the victory wire came off potentially after crossing multiple challenging lesions or difficult calcified areas.Bsc rep was not present during this procedure.

• Brand Name: VICTORY 18 (300 CM, 18G)
• Common Device Name: VICTORY 18 (300 CM, 18G)
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 15860699
• Report Number: 3006010712-2022-00051
• Device Sequence Number: 20263130
• Product Code: DQX
• UDI-Device Identifier: 08714729826699
• UDI-Public: 08714729826699
• Combination Product (Y/N): N
• 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): 01/17/2023

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: 09/30/2024
• Device Model Number: 901023-24
• Device Catalogue Number: H74939232300180
• Device Lot Number: 6715385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 11/16/2022
• Initial Report FDA Received Date: 11/24/2022
• Supplement Report FDA Received Date: 01/09/2023; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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