MAUDE Adverse Event Report: SCIENTIA VASCULAR LLC ARISTOTLE; WIRE, GUIDE, CATHETER

Model Number	ACL-200-002
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Guidewire broke inside the catheter.Pieces were retrieved with no harm to patient.

• Brand Name: ARISTOTLE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): SCIENTIA VASCULAR LLC; 2460 south 3270 west; west valley city UT 84119
• MDR Report Key: 18613039
• Report Number: 18613039
• Device Sequence Number: 15330779
• Product Code: DQX
• UDI-Device Identifier: 00818075010691
• UDI-Public: (01)00818075010691(17)240831(10)023595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/23/2024
• Report Date (Section F): 01/23/2024

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 Model Number: ACL-200-002
• Device Catalogue Number: ACL-200-002
• Device Lot Number: 023595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White
• Date Report Sent to FDA: 01/23/2024