MAUDE Adverse Event Report: SCIENTIA VASCULAR ZOOM WIRE; GUIDEWIRE

Model Number	01064
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a venous manometry case the physician was using a zoom wire 14 x-support guidewire (z14-200-004) when the wire got sticky and some "blue" stuff was coming off on the physicians fingers.One of the staff thought the wire had sheared.The patient was said to be fine and the case was finished.
Additional Manufacturer Narrative
Review of the manufacturing lot history record indicated that the lot met the release criteria.Ptfe was observed to be missing from the returned guidewire, however, given the limited information and not being provided with what interfacing devices were used in the case, it cannot be confirmed to be the blue reported on the physician fingers.Several attempts were made to gather additonal information regarding the case on 22oct2025, 03nov2025, and 17nov2025.

• Brand Name: ZOOM WIRE
• 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 84119
• MDR Report Key: 23611413
• Report Number: 3009546466-2025-00016
• Device Sequence Number: 9258531
• Product Code: MOF
• UDI-Device Identifier: 00818075010240
• UDI-Public: 00818075010240
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 04/30/2026
• Device Model Number: 01064
• Device Catalogue Number: Z14-200-004
• Device Lot Number: 034366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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
• Patient Age: 66 YR
• Patient Sex: Female