MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE GUIDEWIRE; ARISTOTLE 14

Model Number	ARISTOTLE 14
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, scientia vascular received a customer complaint for the aristotle a14-200-002 guidewire.Per the complaint description "when the physician was passing the catheter over the wire as he was removing it, it stretched and broke.The wire was left in the patient, but no patient injury occurred".
Additional Manufacturer Narrative
No other information is available regarding the event.The overall wire length was inspected, and it was found that the break occurred approximately 5.2cm from the distal tip.A high-magnification microscope (100x) was used to evaluate the break location and find a clean break.After the wire breaks the internal coil unravels and separates from the guidewire.Top view inspection of the stainless-steel metal from the returned unit using 3d imaging surfaced, and saw peaks and valleys on the surface of the stainless-steel metal, an indication of a pull/tensile break.
Additional Manufacturer Narrative
The guidewire was returned to scientia vascular for investigation on 11/22/2022.There was no non-conformance generated or reworks done for the lot during the manufacturing process which confirms the lot was built to specification.Visual inspection of the unit after decontamination and inspection of the guidewire under the 10x microscope at the break location and areas around the break location, no anomaly observed on the surface of the guidewire.The retraction of the guidewire and simultaneous advancement of the catheter through tortuous anatomy is likely the cause for the force which contributed to the pull/tensile breaking of the wire.However, the exact cause for the breaking of the wire is still unknown.The procedure was completed successfully, and no patient injury was reported.

• Brand Name: ARISTOTLE GUIDEWIRE
• Common Device Name: ARISTOTLE 14
• Manufacturer (Section D): SCIENTIA VASCULAR; 3487 west 2100 south; suite 100; west valley city UT 84119
• Manufacturer (Section G): SCIENTIA VASCULAR; 3487 west 2100 south; suite 100; west valley city UT 84119
• Manufacturer Contact: niki wong ; suite 100; west valley city, UT 84119
• MDR Report Key: 15978706
• Report Number: 3009546466-2022-00004
• Device Sequence Number: 5784962
• Product Code: DQX
• UDI-Device Identifier: 00818075010011
• UDI-Public: 00818075010011
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173235
• 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): 12/14/2022

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 Expiration Date: 09/30/2023
• Device Model Number: ARISTOTLE 14
• Device Catalogue Number: A14-200-002
• Device Lot Number: 502986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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 CATHETER
• Patient Sex: Unknown