MAUDE Adverse Event Report: LIGHTLAB IMAGING, INC. PressureWire¿; Transducer, Pressure, Catheter Tip

Model Number	C12059
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction

• Brand Name: PressureWire¿
• Common Device Name: Transducer, Pressure, Catheter Tip
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd.; westford MA 01886
• Manufacturer (Section G): Abbott Vascular Costa Rica, Reg # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50936278
• Report Number: 2024168-2026-03755
• Device Sequence Number: 10725487
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715(17)260831(10)40909G1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 08/31/2026
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 40909G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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