MAUDE Adverse Event Report: SpectraWAVE, Inc. Starlight Imaging Catheter; Catheter, Intravascular, Plaque Morphology Evaluation

Model Number	951
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
"it was reported that a starlight catheter was used for a coronary procedure.During use, red thrombus was seen inside the stent post pci in the lad, and treated by ballooning the thrombus to the wall and given integrilin bolus.The catheter had difficulty exiting the guide, and thought the catheter was going to kink.After several attempts, the angle of approach was changed, the catheter entered the vessel with trouble advancing into the pda, but was able to eventually cross with some maneuvering of the guidewire.This adverse event is being submitted because the patient experienced thrombus, requiring additional intervention.There was no alleged malfunction reported with the starlight catheter.".
Event or Problem Description
"it was reported that a starlight catheter was used for a coronary procedure.During use, red thrombus was seen inside the stent post pci in the lad, and treated by ballooning the thrombus to the wall and given integrilin bolus.The catheter had difficulty exiting the guide, and thought the catheter was going to kink.After several attempts, the angle of approach was changed, the catheter entered the vessel with trouble advancing into the pda, but was able to eventually cross with some maneuvering of the guidewire.This adverse event is being submitted because the patient experienced thrombus, requiring additional intervention.There was no alleged malfunction reported with the starlight catheter.".
Additional Manufacturer Narrative
Block a: patient information, not available from facility.Block c: not applicable for this device.Block d4: serial # not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the starlight catheter was not returned for evaluation; thus, no product investigation was performed.Block h6: device history record (dhr) was reviewed and all released units were manufactured to specification, with no ncrs or deviations contributing to the reported complaint.Blocks h7, h9 & h10: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.".
Additional Manufacturer Narrative
Supplemental mdr 1: this report is being submitted as part of a retrospective review stemming from an fda form 483, and is captured in capa-52.Block a: patient information, not available from facility.Block c: not applicable for this device.Block d4: serial # not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the starlight catheter was not returned for evaluation; thus, no product investigation was performed.Block h6: device history record (dhr) was reviewed and all released units were manufactured to specification, with no ncrs or deviations contributing to the reported complaint.Blocks h7, h9 & h10: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.".

• Brand Name: Starlight Imaging Catheter
• Common Device Name: Catheter, Intravascular, Plaque Morphology Evaluation
• 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
• MDR Report Key: 50452902
• Report Number: 3017654247-2026-00011
• Device Sequence Number: 13383791
• Product Code: OGZ
• UDI-Device Identifier: 00860008045508
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K243016
• 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,Followup
• Report Date (Section B): 09/09/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2026
• Device Model Number: 951
• Device Catalogue Number: 951
• Device Lot Number: 100261
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SpectraWAVE: HyperVue Imaging System Mobile; SpectraWAVE: HyperVue Imaging System Mobile; Unk Mfg and Size: Guide Catheter; Unk Mfg and Size: Guide Catheter; Unk Mfg and Size: Guidewire; Unk Mfg and Size: Guidewire; Unk Mfg and Size: Introducer Sheath; Unk Mfg and Size: Introducer Sheath
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown