MAUDE Adverse Event Report: SCIENTIA VASCULAR, LLC ARISTOTLE; GUIDEWIRE

Model Number	A14-200-002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further high-resolution inspection of the failure surfaces using sem will be performed next.However, this is dependent on external laboratory availability.This laboratory is closed for outside visitation and has limited availability due to the covid-19 pandemic.
Event or Problem Description
From complainant, "last week we had a distal pca aneurysm we were using an aristotle wire and it fractured about 8 inches from the tip.Have you seen this or has it been reported?- thankfully we were able to slowly withdraw the microcatheter and get the wire out.I am not sure if (b)(6) saved it.It seemed to have broken with one long microfilament that went down the catheter.".
Additional Manufacturer Narrative
The complaint of a broken guidewire was confirmed; however, the cause could not be established at this time.Visual, microscopic, sem, and eds evaluations of the device suggests that the guidewire was subjected to significant torsional and tensile stresses which led to failure.However, no evidence of any material defects, manufacturing defects, or other anomalies were identified.The non-conformance report (ncr) log and the lot history record (lhr) for the reported lot number was reviewed for any applicable manufacturing anomalies and none were found.No similar complaints have been reported for this lot number.

• Brand Name: ARISTOTLE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): SCIENTIA VASCULAR, LLC; 3487 west 2100 south; suite 100; west valley city, ut
• MDR Report Key: 10474526
• Report Number: 3009546466-2020-00002
• Device Sequence Number: 14257676
• Product Code: DQX
• UDI-Device Identifier: 00818075010011
• UDI-Public: 00818075010011
• Combination Product (Y/N): N
• 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): 11/16/2020

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: 09/30/2022
• Device Model Number: A14-200-002
• Device Catalogue Number: A14-200-002
• Device Lot Number: 500756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1