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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction

• 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: 50452907
• Report Number: 3017654247-2026-00016
• Device Sequence Number: 10487566
• Product Code: OGZ
• UDI-Device Identifier: 00860008045508
• UDI-Public: (01)00860008045508(17)260719(10)100309
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2026
• Device Model Number: 951
• Device Catalogue Number: 951
• Device Lot Number: 100309
• 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: 04/24/2026
• 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: 01/20/2026
• 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 Sex: Unknown