MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE; GUIDEWIRE

Model Number	ARISTOTLE COLOSSUS GUIDEWIRE, 200CM, STANDARD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 13 may 2024, scientia vascular employee was notified that a doctor was using an acl-200-002 lot #026031 during an aspiration thrombectomy procedure, and the distal portion of the guidewire broke during the case.The broken portion of the guidewire was captured in the zoom pod already set up for the procedure.
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 it confirms the lot met the releasing criteria.There is no way to confirm every step taken that could have led the guidewire to break.However, no indication of a manufacturing defect was found on the investigation of the returned guidewire.It appears that the guidewire tip interaction with the microcatheter and the vasculature could have been the cause for the guidewire break.

• Brand Name: ARISTOTLE
• 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: 19512875
• Report Number: 3009546466-2024-00006
• Device Sequence Number: 7489216
• Product Code: MOF
• UDI-Device Identifier: 00818075010691
• UDI-Public: 00818075010691
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: 02/12/2025
• Device Model Number: ARISTOTLE COLOSSUS GUIDEWIRE, 200CM, STANDARD
• Device Catalogue Number: ACL-200-002
• Device Lot Number: 026031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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: BMX GUIDE SHEATH; ZOOM 71 ASPIRATION CATHETER
• Patient Sex: Unknown