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

Model Number	C12059
Medical Device Problem Codes	Difficult to Remove (1528); Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection and additional testing methods were performed on the returned device.The reported communication issue was confirmed due to an open circuit.The reported difficulty removing the pressurewire from the dispenser coil was unable to be confirmed due to the condition of the returned device and the original dispenser coil was not returned.Production record and corrective and preventative actions (capa) reviews were performed and revealed one related complaint assessment capa.Additionally, a query of the complaint handling database for the reported lot revealed one other similar complaint related to the capa.Although the reported difficulty removing from the dispenser coil was unable to be confirmed, a potential product quality issue has been identified related to difficulty removing the pressurewire from the dispenser coil; therefore, a capa has been initiated.The reported communication problem appears to be due damage to the internal components causing the noted open circuit.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
Reportedly, two pressurewire x (pwx) wireless devices (51122g1) were used during the procedure.The first pwx was difficult to remove from the hoop during preparation.After removal from the hoop, the device was calibrated and equalization was successful.After equalization, there was no green pressure curve present, and the transmitter was green.The device was removed, and the procedure continued with the second device.The second pwx device could not be equalized.The device was removed and the procedure was completed without a replacement device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.During product return investigation, the distal tube had cuts and tearing of the polyimide tubing along its entire length.

• 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: 24821584
• Report Number: 2024168-2026-01435
• Device Sequence Number: 18549427
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715(17)271031(10)51122G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/08/2026

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: 51122G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2025
• 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