MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE COLOSSUS; GUIDEWIRE

Model Number	ARISTOTLE COLOSSUS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On the 31 of march 2023, scientia vascular was notified that an aristotle colossus guidewire (catalog # acl-200-002 ln:021376) stretched and sheared off during a neurovascular procedure.The event was described as follows: "the colossus guidewire stretched and then shared off during the 2nd thrombectomy aspiration pass.A portion of the guidewire was left in the distal mca.In total the physician performed 9 passes due to the extensive thrombus burden." the doctor informed the patient of the guidewire fracture and mentioned the patient was doing well, and that the guidewire breaking did not offer any adverse effect.The remaining portion of the complaint unit was returned to scientia vascular for evaluation on (b)(4)2023.
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.The investigation indicates the guidewire may have been damaged during the 2nd thrombectomy aspiration pass, then broke during the pass.However, there is no way to confirm every step taken that could have led the guidewire to break during this procedure, therefore, the root cause of this complaint could not be determined.Because the procedure was completed successfully, no patient injury was reported for this complaint.

• 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: 16839604
• Report Number: 3009546466-2023-00004
• Device Sequence Number: 7547321
• Product Code: MOF
• UDI-Device Identifier: 00818075010691
• UDI-Public: 00818075010691
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: 222437
• 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
• Report Date (Section B): 04/28/2022

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
• Device Expiration Date: 02/28/2024
• Device Model Number: ARISTOTLE COLOSSUS
• Device Catalogue Number: ACL-200-002
• Device Lot Number: 021376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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: ESPERANCE 6F ASPIRATION CATHETER, 0.071" ID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male