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

Model Number 901023-24

Device Problems Flaked (1246); Peeled/Delaminated (1454); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

Event 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 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.

Manufacturer Narrative

Complaint investigation report is attached to this report.

Manufacturer Narrative

Complaint investigation report is attached to this report.

Event 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)
• Type of Device: 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
• MDR Text Key: 304292103
• Report Number: 3006010712-2022-00051
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729826699
• UDI-Public: 08714729826699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 901023-24
• Device Catalogue Number: H74939232300180
• Device Lot Number: 6715385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: 11/16/2022; 11/16/2022
• Supplement Dates FDA Received: 01/09/2023; 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1