MAUDE Adverse Event Report: BRIVANT LIMITED VICTORY 18 (300CM, 30G)

Model Number	901023-32
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Md was attempting to cross a heavily calcified lesion from the pedal approach.During the attempt to cross, the distal tip of the wire broke off within the cto.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none.What is the next course of action?: leave the tip in the body as no way to snare the tip.Patient present at time of event?: yes patient complications: other in the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes.Please describe the way in which the device or procedure caused or contributed to the patient complication?: the tip of the wire broke off in the patients leg.Medical or surgical interventions: none.Patient admitted to hospital beyond the standard of care: no patient outcome: unknown.Reason for unsuccessful procedure: the tip of the wire was left in the body and the md was unable to cross the cto.Was the patient sedated when the procedure was cancelled?: yes - local anesthesia.
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
Md was attempting to cross a heavily calcified lesion from the pedal approach.During the attempt to cross, the distal tip of the wire broke off within the cto.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: none what is the next course of action?: leave the tip in the body as no way to snare the tip.Patient present at time of event?: yes patient complications: other in the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes please describe the way in which the device or procedure caused or contributed to the patient complication?: the tip of the wire broke off in the patients leg.Medical or surgical interventions: none patient admitted to hospital beyond the standard of care: no patient outcome: unknown reason for unsuccessful procedure: the tip of the wire was left in the body and the md was unable to cross the cto.Was the patient sedated when the procedure was cancelled?: yes - local anesthesia.

• Brand Name: VICTORY 18 (300CM, 30G)
• Common Device Name: VICTORY 18 (300CM, 30G)
• Manufacturer (Section D): BRIVANT LIMITED; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer (Section G): BRIVANT LIMITED; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer Contact: krishna priya kodumadu venkittaraman ; parkmore west business park; galway, H91CK-22 ; EI H91CK22
• MDR Report Key: 15232809
• Report Number: 3006010712-2022-00032
• Device Sequence Number: 20406532
• Product Code: DQX
• UDI-Device Identifier: 00816349012426
• UDI-Public: 00816349012426
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/26/2022

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 Model Number: 901023-32
• Device Catalogue Number: H74939233300300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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