MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE COLOSSUS; GUIDEWIRE

Model Number	ARISTOTLE COLOSSUS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
From the review of the manufacturing lot history record, there is no indication that the break occurred due to a manufacturing defect, and the lot met the releasing criteria.No manufacturing related issues were found during the investigation of this complaint.Even after several attempts to acquire more information about this complaint, no additional information was provided.The break of the guidewire is confirmed; however, investigation suggests that the guidewire breakage occurred due to the external forces applied on the guidewire after the guidewire getting caught in a branch vessel as described during the complaint intake.Instructions for use (ifu) for the aristotle colossus guidewire states warning sections states that: "the aristotle colossus guidewire should be manipulated under fluoroscopy.Do not attempt to move the guidewire without observing the resulting tip response.Advance and withdraw the guidewire slowly and carefully.Never advance or withdraw the guidewire against resistance that is felt or observed under fluoroscopy until the cause of the resistance is determined.Movement of the guidewire against resistance may result in damage to the guidewire or injury to the patient.".
Event or Problem Description
On the 11th of jul 2024, a scientia vascular employee was notified of a complaint about an aristotle colossus (acl-200-002 ln: 027057) guidewire tip breaking after getting stuck in a branch vessel.The complaint guidewire was returned to scientia vascular on the 2nd of aug 2024.No updates on patient status were provided.
Additional Manufacturer Narrative
From the review of the manufacturing lot history record, there is no indication that the break occurred due to a manufacturing defect, and the lot met the releasing criteria.No manufacturing related issues were found during the investigation of this complaint.Even after several attempts to acquire more information about this complaint, no additional information was provided.For these reasons, a true root cause for the break could not be obtained.

• Brand Name: ARISTOTLE COLOSSUS
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): SCIENTIA VASCULAR; 2460 south 3270 west; west valley city UT 84119
• Manufacturer (Section G): SCIENTIA VASCULAR; 2460 south 3270 west; west valley city UT 84119
• Manufacturer Contact: raquel johnson ; 2460 south 3270 west; west valley city, UT 84119
• MDR Report Key: 19956370
• Report Number: 3009546466-2024-00010
• Device Sequence Number: 15667566
• Product Code: MOF
• UDI-Device Identifier: 00818075010691
• UDI-Public: 00818075010691
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K222437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: ARISTOTLE COLOSSUS
• Device Catalogue Number: ACL-200-002
• Device Lot Number: 027057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/26/2024; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SOFIA MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown