MAUDE Adverse Event Report: LIGHTLAB IMAGING, INC. PRESSUREWIRE¿; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	C12059
Medical Device Problem Codes	Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection and additional testing methods were performed on the returned device.The reported faulty pressure registration was not able to be confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported faulty pressure registration appears to be related to operational context.The device was returned with damage to the pressure sensor of the guidewire, which resulted in the reported and confirmed pressure registration issue.The pressure sensitivity of the guidewire is tested during the manufacturing process and prior to release to device functionality upon expected use.In this case, it is likely that the damage to the pressure membrane of the sensor chip occurred due to the handling or use techniques employed.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Reportedly, the pwx device was calibrated successfully.While attempting equalization, there was a large difference between the pa and pd value, and equalization could not be achieved.The transmitter was green.Therefore, the device was removed and another pwx device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.During product return investigation, it was observed that there was a break in the pressure sensor membrane.

• 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 92591-4628 ; 9519143996
• MDR Report Key: 24618010
• Report Number: 2024168-2026-01051
• Device Sequence Number: 18725651
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715(17)270531(10)50619G1
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 03/17/2026

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 Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 50619G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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 Sex: Unknown