MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE 14; GUIDEWIRE

Model Number	ARISTOTLE 14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
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 it determined the lot met the releasing criteria.There is no way to confirm every step taken that could have led the guidewire to break, but from the information collected in this investigation, the guidewire appears to have bent during the procedure and the bend may have been fatigued during use.The bend may have been further stressed when the physician torqued the device after it was stuck until it broke.An attempt to submit the emdr was performed on 08-nov-2023, and on 09-nov-2023.However, the account certificate needed to be processed by the esg help desk and be ready for use.This activity led to a submission delay that went over the 30 days fda requirement for this type of emdr.The esg help desk suggested that this information be enter in this tab.
Event or Problem Description
On the 10th of october 2023, scientia vascular was notified that an aristotle 14 guidewire (catalog # a14-200-002 ln:022981) broke during a procedure.The event was described as follows: "the guidewire got stuck.Physician continued to torque the device, could not get the guidewire out, guidewire ended up breaking inside the patient, however the doctor was able to use a snare to remove the guidewire from the patient.There was no patient injury reported for this event.".

• Brand Name: ARISTOTLE 14
• 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: 18141750
• Report Number: 3009546466-2023-00006
• Device Sequence Number: 6559606
• Product Code: MOF
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 07/31/2023
• Device Model Number: ARISTOTLE 14
• Device Catalogue Number: A14-200-002
• Device Lot Number: 022981
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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: SL-10 MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown