MAUDE Adverse Event Report: LAKE REGION MEDICAL VICTORY 14 (300CM, 30G)

Model Number	901023-30
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
4 opticrosses, 3 angioplasty balloons and 1 victory 14 wire caused some problems during the cases.Details are as below.Opticross 18 the surgical techncianhas 4 opticross 18 which are faulty devices.2 of them stopped projecting images in the middle of using the ivus, so she opened another brand new one and worked perfectly fine.2 of them had issues with the connector that connects to the actual mdu devices and did not give any images.Coyote 2 x 40 x 144 · sterling 4 x 40 x 135 · sterling 6 x 80 x 135 all above 3 balloons burst during the cases without reaching the maximum burst pressure of each balloon.· 1 victory 14 (30 grams) wire the tip of the wire broken into pieces while using for the case.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Additional Manufacturer Narrative
Complaint investigation report is attached to this report.
Event or Problem Description
4 opticrosses, 3 angioplasty balloons and 1 victory 14 wire caused some problems during the cases.Details are as below.· opticross 18 the surgical techncian has 4 opticross 18 which are faulty devices.2 of them stopped projecting images in the middle of using the ivus, so she opened another brand new one and worked perfectly fine.2 of them had issues with the connector that connects to the actual mdu devices and did not give any images.· coyote 2 x 40 x 144 · sterling 4 x 40 x 135 · sterling 6 x 80 x 135 all above 3 balloons burst during the cases without reaching the maximum burst pressure of each balloon.· 1 victory 14 (30 grams) wire the tip of the wire broken into pieces while using for the case.

• Brand Name: VICTORY 14 (300CM, 30G)
• Common Device Name: VICTORY 14 (300CM, 30G)
• 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: 17037105
• Report Number: 3006010712-2023-00027
• Device Sequence Number: 6898115
• Product Code: DQX
• UDI-Device Identifier: 08714729826651
• UDI-Public: 08714729826651
• 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
• Report Date (Section B): 07/27/2023

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: 05/31/2023
• Device Model Number: 901023-30
• Device Catalogue Number: H74939231300300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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