MAUDE Adverse Event Report: SCIENTIA VASCULAR ZOOM; GUIDEWIRE

Model Number	01066
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
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 confirms the lot met the releasing criteria.
Event or Problem Description
It was reported that a zoom 14 guidewire fractured during a procedure.It was noted there was a vessel dissection of the carotid during the procedure and was treated without complication.It was noted that a vessel dissection occurred in the carotid but the doctor could not confirm it was caused by the guidewire.The doctor was using the guidewire to pass the stent and deploy a balloon.The wire had a "j" shape for the tip but it was not working as well as the doctor wanted and decided to remove the guidewire.Upon removal it was noticed that the guidewire had broken and the broken piece of the wire was found in the hemostasis valve.There was no injury to the patient and no other intervention.

• Brand Name: ZOOM
• 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: joshua verlac ; 2460 south 3270 west; west valley city, UT 84119
• MDR Report Key: 24319401
• Report Number: 3009546466-2026-00032
• Device Sequence Number: 10212874
• Product Code: MOF
• UDI-Device Identifier: 00818075010264
• UDI-Public: 00818075010264
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 01066
• Device Catalogue Number: Z14-300-004
• Device Lot Number: 024258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: FRED STENT FLOW DIVERTER.; PENUMBRA BENCHMARK BMX 81 CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown