MAUDE Adverse Event Report: SPECTRAWAVE, INC STARLIGHT IMAGING CATHETER; OPTICAL COHERENCE TOMOGRAPHY IMAGING CATHETER

Model Number	951
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event summary: a patient experienced ventricular fibrillation (vfib) during a coronary imaging procedure, shortly after a manual saline injection (using a syringe) was administered to clear the vessel of blood.This injection was a standard clinical step performed under physician control and discretion to prepare the vessel prior to imaging.In this case the physician chose to use the hypervue imaging system & starlight catheter.The saline flush was not controlled or delivered by the device, and not performed automatically by any device function.The patient was defibrillated which stabilized patient's heart rhythm.A subsequent pullback using a contrast injection as the flush medium was completed.Device involvement assessment: following is based on event information reported and initial investigation of the event details.· when the device was used it functioned per specifications and did not malfunction.· the adverse event occurred in the context of a physician-controlled step and was not due to any malfunction, improper use, inadequate design, manufacture or labeling of the device.· the event is considered related to the procedure, not the device.Note: use of saline or contrast for vessel flush for intravascular imaging is determined by the physician, including the methodology, volume, and flow of injection.Initial reportability assessment: the initial assessment of this event determined that it does not meet the criteria for mandatory medical device reporting under 21 cfr 803, as the device did not cause or contribute to a death or serious injury, nor did it malfunction in a way that could lead to such an outcome.However, in the interest of transparency, and to support fda's postmarket surveillance efforts, we are voluntarily submitting this report to inform fda of the event and our ongoing monitoring and investigation of similar occurrences.No corrective or preventive action is currently warranted based on the information available.

• Brand Name: STARLIGHT IMAGING CATHETER
• Common Device Name: OPTICAL COHERENCE TOMOGRAPHY IMAGING CATHETER
• Manufacturer (Section D): SPECTRAWAVE, INC; 12 oak park drive; bedford MA 01730
• Manufacturer (Section G): SPECTRAWAVE, INC.; 12 oak park drive; bedford MA 01730
• Manufacturer Contact: ankit shah ; 12 oak park drive; bedford, MA 01730 ; 3234016480
• MDR Report Key: 21998173
• Report Number: 3017654247-2025-00001
• Device Sequence Number: 9484400
• Product Code: NQQ
• UDI-Device Identifier: 00860008045508
• UDI-Public: 00860008045508
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K230691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2025
• Device Model Number: 951
• Device Catalogue Number: 951
• Device Lot Number: 100203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown